[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-adenocarcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,44,67,89,121,150,178,198,229,278,304,337,375,396,420,446,468,490,522,551,579,603,624,649,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100634986","phase-2-study-of-denikitug-gs-1811-given-alone-or-with-nivolumab-or-chemotherapy-in-adults-with-metastatic-gastric-gastroesophageal-junction-gej-and-esophageal-adenocarcinomas-100634986",false,"NCT07546812","Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and\u002For Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a validated immunohistochemistry assay, in situ hybridization or other amplification testing.\n* Has had disease progression during or after first line of systemic therapy for advanced or metastatic gastric, GEJ, or EACs, which must have included at least one of the following:\n\n  1. Platinum- and fluoropyrimidine-based chemotherapy.\n  2. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1\u002FPD-L1-based therapy).\n  3. Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Have adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n\nKey Exclusion Criteria:\n\n* Active or history of autoimmune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's\u002Fulcerative colitis), celiac disease, or noninfectious enteritis\u002Fcolitis. (Physiologic hormone replacement not considered systemic treatment).\n* History or current noninfectious pneumonitis\u002Finterstitial lung disease, including radiation-induced pneumonitis requiring steroids or active\u002Frecurrent pneumonitis of any etiology.\n* Documented microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease by local polymerase chain reaction (PCR) (microsatellite status) and\u002For informed consent form (ICH) (mismatch repair (MMR)) assay\n* (For Part 2 only) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTCAE) Version 5.0).\n* (For Part 2 only) Known coagulopathy that increases the risk of bleeding, bleeding diatheses. Any other Grade 3 or higher hemorrhage\u002Fbleeding event within 28 days prior to enrollment.\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience\n\n* Prior treatment with DEN or other C-C chemokine receptor 8 (CCR8)-targeted agents.\n* Prior Lonsurf (trifluridine-tipiracil) or paclitaxel (PAC)-based regimens in the first-line setting for advanced\u002Fmetastatic gastroesophageal adenocarcinoma.\n* Any systemic therapy (including investigational) targeting vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) signaling pathways.\n* Anticancer biologic within 4 weeks, orchemotherapy, targeted small molecule, or radiation therapy within 2 weeks prior to enrollment with unresolved adverse events (AE)s (Grade \\>2). (Observational study participants are eligible).\n* Prior allogenic tissue\u002Fsolid organ or stem cell transplantation. (Exception: corneal transplant not requiring systemic immunosuppression is allowed).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and\u002For metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.\n\nThe primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).",[27,28,29,30],"HER2-negative","Gastroesophageal Junction","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-08-07",{"date":39,"type":21},"2030-01",{"name":41,"class":42},"Gilead Sciences","INDUSTRY",12,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100641343","phase-2-gi-05-the-impact-of-olanzapine-among-patients-receiving-neoadjuvant-chemotherapy-for-gastric-cancer-100641343","NCT07581405","GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2\n* Histologically confirmed gastric adenocarcinoma, documented by biopsy.\n* Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.\n* Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Patients with a feeding tube (e.g., gastrostomy or jejunostomy) receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment.\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity, as determined by the study PI",{"count":51,"type":21},26,[24],"This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.",[30,55],"Gastric Cancer","NOT_YET_RECRUITING","2026-08-19",{"date":34,"type":35},{"date":60,"type":21},"2026-09",{"date":62,"type":21},"2030-09",{"name":64,"class":65},"University of Illinois at Chicago","OTHER",1,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":66},"100652676","phase-2-iparomlimab-and-tuvonralimab-injection-ql1706-combined-with-dos-as-neoadjuvant-therapy-for-locally-advanced-adenocarcinoma-of-the-stomach-and-gastroesophageal-junction-100652676","NCT07776639","Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction","A Single-Arm, Prospective, Open-Label Clinical Study of Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction","Inclusion Criteria:\n\n* Aged 18-75 years old, male or female;\n* Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction;\n* Clinical stage cT3-4a\u002FN+M0;\n* ECOG performance status 0-1;\n* Adequate function of major organs assessed within 7 days before treatment:\n\n  1. Hematological indicators (without blood transfusion within 14 days):\n\n     Hemoglobin (HB) ≥90 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelet (PLT) ≥80×10⁹\u002FL;\n  2. Biochemical indicators:\n\n     Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 ml\u002Fmin;\n  3. Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);\n  4. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN;\n* Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment;\n* Subjects voluntarily participate in this study and sign written informed consent.\n\nExclusion Criteria:\n\n* Inclusion Criteria:\n* Aged 18-75 years old, male or female;\n* Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction;\n* Clinical stage cT3-4a\u002FN+M0;\n* ECOG performance status 0-1;\n* Adequate function of major organs assessed within 7 days before treatment:\n\n  1. Hematological indicators (without blood transfusion within 14 days):\n\n     Hemoglobin (HB) ≥90 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelet (PLT) ≥80×10⁹\u002FL;\n  2. Biochemical indicators:\n\n     Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 ml\u002Fmin;\n  3. Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);\n  4. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN;\n* Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment;\n* Subjects voluntarily participate in this study and sign written informed consent.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any component of QL1706, tegafur-gimeracil-oteracil potassium, oxaliplatin, docetaxel, or any of their excipients;\n* History of other malignant tumors within the past 5 years or concurrent other malignant tumors, except cured carcinoma in situ of cervix, non-melanoma skin cancer, and superficial bladder tumors;\n* Patients with distant metastasis or unresectable disease;\n* Prior receipt of immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);\n* Received any anti-tumor agents within 4 weeks prior to the first study drug administration;\n* Patients with intestinal obstruction (including incomplete intestinal obstruction) or other gastrointestinal diseases that may lead to gastrointestinal hemorrhage, perforation or obstruction;\n* Patients with any bleeding event ≥ CTCAE Grade 3, unhealed wounds, ulcers or fractures within 4 weeks before screening;\n* Concurrent enrollment in another interventional clinical trial, except observational (non-interventional) clinical trials or follow-up phase of interventional trials;\n* Subjects requiring systemic treatment with corticosteroids (\\>10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks before the first study drug administration;\n* Received live vaccines within 4 weeks prior to the first study drug administration;\n* Underwent major surgery or suffered trauma within 4 weeks before the first study drug administration;\n* Active autoimmune disease or history of autoimmune disease, except vitiligo or childhood asthma\u002Fallergy that has resolved and requires no intervention in adulthood;\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;\n* Subjects with inadequately controlled cardiovascular clinical symptoms or diseases;\n* Severe infection (CTCAE Grade \\> 2) occurring within 4 weeks prior to the first study drug administration;\n* History of interstitial lung disease (except radiation pneumonia without corticosteroid treatment), non-infectious pneumonia, active pulmonary tuberculosis infection; patients with history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with history of active pulmonary tuberculosis infection more than 1 year ago without standardized treatment;\n* Pregnant or breastfeeding women;\n* Other concomitant diseases that, in the investigator's opinion, may seriously endanger the subject's safety or prevent the subject from completing the study.","75 Years",{"count":76,"type":21},34,[24],"This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). The study aims to further explore the efficacy and safety of iapalolimab plus DOS regimen for locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma will be enrolled. Each treatment cycle lasts 21 days. After 3-4 cycles, patients who are assessed as operable by investigators will undergo surgical resection, and postoperative pathological results will be evaluated. The primary outcome measure is the pathological complete response rate. Investigators will determine subsequent treatment regimens based on patients' pathological findings and routine clinical practice at the study center. Radiological assessment of tumor response is recommended every 2 cycles.",[80,30],"Gastroesophageal Junction Adenocarcinoma","2026-08-17",{"date":32,"type":35},{"date":84,"type":35},"2026-05-10",{"date":86,"type":21},"2028-11",{"name":88,"class":65},"Yongxu Jia",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":110,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100606945","phase-1-a-phase-1-study-of-nrm-823-in-participants-with-locally-advanced-or-metastatic-refractory-solid-tumors-100606945","NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.",{"count":97,"type":21},150,[99],"PHASE1","This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[102,103,29,30,104,105,106,107,108,109],"HNSCC","ESCC","GEJ Adenocarcinoma","Ovarian Cancer","NSCLC","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer (TNBC)",[111],"NRM-823",{"date":113,"type":35},"2026-08-18",{"date":115,"type":35},"2025-10-30",{"date":117,"type":21},"2028-10-31",{"name":119,"class":42},"Normunity AccelCo, Inc.",18,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100593077","phase-2-testing-the-addition-of-paclitaxel-administered-into-the-abdominal-cavity-combined-with-chemotherapy-for-patients-with-gastric-cancer-spread-to-the-abdominal-cavity-100593077","NCT07001748","Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity","Protocol EA2234: A Randomized Phase II\u002FIII Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II","STOPGAP II","STEP 0 REGISTRATION:\n\n* Patient must be at least 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H\u002FdMMR) mismatch repair deficient disease are not eligible\n* Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment\n* Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy\n* Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy\n* Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration\n* Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy\n* Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy\n* Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement\n* Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin\n* Leukocytes ≥ 2,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (≤ 30 days prior to Step 0 registration)\n* Platelets ≥ 75,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \\\u003C 2.0 mg\u002FdL (≤ 30 days prior to Step 0 registration)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration)\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)\n* Hemoglobin ≥ 8 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Serum albumin ≥ 2.5 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n\nSTEP 1 RANDOMIZATION:\n\n* Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained\n* The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available\n* Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port",{"count":130,"type":21},148,[24,132],"PHASE3","This study is being done to answer the following questions:\n\nCan we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer.\n\nIf you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below.\n\nIf you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen).\n\nIf you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment.\n\nIt is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in.\n\nOnce you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon.\n\nThere is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called \"intra-abdominal adhesions\". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help.\n\nAfter you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest\u002FAbdomen\u002FPelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.",[30,80,135],"Peritoneal Carcinomatosis",[137,138,127,139,140],"EA2234","Intraperitoneal Paclitaxel","STOPGAP I","Gastric Carcinomatosis",{"date":57,"type":35},{"date":143,"type":35},"2025-08-19",{"date":145,"type":21},"2030-05-30",{"name":147,"class":148},"ECOG-ACRIN Cancer Research Group","NETWORK",78,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":120},"100520663","phase-2-watch-and-wait-approach-with-dostarlimab-in-localized-dmmrmsi-h-gastric-cancer-gercor-phase-ii-study-100520663","NCT06059495","DEWI: Watch-and-Wait With Dostarlimab in Localized dMMR\u002FMSI-H Gastric\u002FGEJ Adenocarcinoma Phase II Study","Watch-and-wait Strategy to Initiate Dostarlimab-based Immunotherapy in Localized Deficient Mismatch Repair (dMMR) and\u002For Microsatellite Instability High (MSI-H) oEso-gastric Junction and Gastric Adenocarcinoma: An Open-label GERCOR Phase II Study","DEWI","Inclusion and exclusion criteria are identical in both cohorts, except for inclusion criteria 3 and 4.\n\nInclusion criteria\n\nThe patient is eligible to be included in the study only if all the following criteria apply:\n\n1. Is capable of giving signed and dated informed consent,\n2. Has an ECOG PS of 0-1,\n3. Age ≥18 years old:\n\n   * A patient over 70 years of age is eligible to participate in the main initial cohort if the patient respects all the criteria and has a score G8 of ≥14.\n   * A patient over 70 years with a score G8 \\\u003C14 should have a consultation with an onco-geriatrician to determine the best treatment or therapeutic strategy based on age and co-morbidity. After this consultation, the patient is eligible for main initial cohort if \"fits for surgery\" with no contraindications to repeated UGI endoscopy with biopsies (no change to the initial protocol) and can follow the study plan and procedures outlined in the study.\n   * If a patient is over 70-year-old, has a G8 score \\\u003C14, and is unfit for surgery (as determined by onco-geriatric advice and multidisciplinary team \\[MDT\\] conclusion), the patient cannot be included in the phase II study (main initial cohort). This patient can be included in the unfit supplemental cohort, with the available Geriatric Core Dataset (G-CODE) test result being mandatory for inclusion (No switching between cohorts is allowed).\n4. Has histologically proven non-metastatic gastric or OGJ adenocarcinoma cT2 to T4, Nx, M0 after computed tomography thorax-abdomen-pelvis (TAP-CT) and echo-endoscopy (EUS), performed within 6 weeks before inclusion, according to the 7th Edition of the International Union Against Cancer; NB1: Echo-endoscopy will be performed only if the tumor is not obstructive at UGI endoscopy ± a new UGI endoscopy with 10 biopsies, photos (if not done at the first UGI endoscopy done for diagnosis). If obstructive, the tumor will be classified as cT3 or cT4 (in the situation when the tumor was obstructive and prevented EUS, it was classified T3N+, if it did not invade the adjacent organs on CT scan, because obstructing tumors represented locally advanced disease in the vast majority of cases in previous studies). In this case a new UGI endoscopy must be done with 10 biopsies, photos (if not done at the first GGI endoscopy done for diagnosis).\n\n   NB2: Echo endoscopy is not mandatory\u002Fperformed for patient included in additional unfit cohort. TNM stage will be determine by CT scanner.\n5. Has no peritoneal carcinomatosis (optional coelioscopy; recommended in case of doubt\u002F suspicious on CT\u002F imaging),\n6. Has not received prior therapy (chemotherapy, radiotherapy, or immunotherapy) for localized gastric or OGJ adenocarcinoma,\n7. Tumor status confirmed to be dMMR\u002FMSI-H as follows:\n\n   \\- MMR protein expression status will be evaluated by immunohistochemistry (IHC) with four antibodies (anti-hMLH1, anti-hMSH2, anti-hMSH6, anti-hPMS2) according to the local procedures. dMMR will be defined as loss of MLSH1 and PMS2, loss of MSH2 and MSH6, or loss of only one protein with presence of MSI-H.\n\n   MSI analysis will be performed by polymerase chain reaction \\[PCR\\] using a pentaplex panel (BAT-25, BAT-26, NR-21, NR-24, and NR-27; PROMEGA). MSI-H is defined as instability in two or more of the five studied markers. For this study, samples with 2 unstable markers will also undergo MMR analysis by IHC. Agreement of Sponsor (GERCOR) on a dMMR\u002FMSI status is mandatory to include the patient (the patient's file \\[an anonymized mail\\] must be sent to Sponsor). Approval\u002Frefusal email for inclusion of the patient will be sent by the Sponsor within 24 hours of receipt of the Investigator email. In case of discrepancy between IHC and PCR, the final decision about the dMMR\u002FMSI status will be taken by GERCOR or coordinating investigator,\n8. Has hematological status: absolute neutrophil count (ANC) ≥1.5 x 109\u002FL; platelets ≥100 x 109\u002FL; hemoglobin ≥9 g\u002FdL,\n9. Has adequate renal function: serum creatinine level ≤150 µM and clearance ≥30 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault),\n10. Has adequate liver function: ≤1.5 x upper limit of normal (ULN) of direct bilirubin ≤ ULN for participants with total bilirubin levels \\>1.5 x ULN (inclusion possible if known Gilbert syndrome), alkaline phosphatase \\\u003C5 x ULN, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5 x ULN,\n11. Has international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 x ULN, except for the patient on anticoagulant therapy who must have PT-INR-aPTT within therapeutic range is deemed appropriate by the Investigator,\n12. Has radiological tumor assessment at screening performed within 6 weeks before inclusion according to RECIST version 1.1 by chest, abdomen, and pelvis CT, showing the absence of metastatic or non-surgical disease,\n13. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n    * Is a woman of non-childbearing potential as defined: i\u002F ≥ 45 years of age and has not had menses for \\>1 year, ii\u002F Amenorrheic for \\\u003C2 years without a hysterectomy and oophorectomy and have a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, iii\u002F post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, magnetic resonance imaging (MRI), or CT scan. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must fulfill the criteria in Inclusion criteria 15. Information must be captured appropriately within the site's source documents,\n    * Has negative pregnancy blood test within 72 hours before the first dose of dostarlimab, AND\n    * If woman of childbearing potential (WOCBP), female patient must be willing to use a highly effective form of contraception from screening throughout the study treatment and 4 months after the last dose of dostarlimab,\n14. Male participants are eligible to participate if they agree to the following during the study treatment and for 4 months after the last dose of dostarlimab:\n\n    * Refrain from donating sperm,\n    * Must use contraception\u002Fbarrier as follows:\n\n      * Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.\n      * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,\n15. Provides primary tumor tissue samples (processed as formalin-fixed, paraffin-embedded \\[FFPE\\] blocks or freshly frozen) acquired during UGI endoscopy together with images (mandatory), NB: The patient's agreement will be specifically requested for endoscopic images in the patient information note and informed consent for their use as clinical data that may be analyzed and presented in publications. These data will be used in the same manner as other personal data. The confidentiality of these data will be maintained,\n16. Is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,\n17. Is registered in the National Health Care System (PUMa - Protection Universelle Maladie included).\n\nExclusion criteria\n\nThe patient is ineligible for the study if any of the following criteria apply:\n\n1. Has received prior concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),\n2. Has received treatment with any investigational medicinal product within 28 days prior to study entry,\n3. Has a treatment anticoagulant or hemostasis disorder contraindicating - biopsies during endoscopy,\n4. Has had major surgical procedure within 28 days (4 weeks) prior to the first dose of study treatment,\n5. Has other serious and uncontrolled non-malignant disease (including active infection) or is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study,\n6. Has other concomitant or previous malignancy other than the disease under study, except as noted below:\n\n   i\u002F adequately treated in-situ carcinoma of the uterine cervix, ii\u002F basal or squamous cell carcinoma of the skin, iii\u002F cancer from which the patients was in complete remission for ≥3 years,\n7. Has metastases (M stage disease) whatever the location,\n8. Is pregnant or breastfeeding,\n9. Has human immunodeficiency virus (HIV),\n10. Has a documented hepatitis B surface antigen (HBsAg) positive result wither at the pre-inclusion visit or within 3 months prior to the first dose of the study intervention, along with and known active hepatitis, including acute or chronic hepatitis B virus (HBV).\n\n    Exception: For patients who are HBsAg positive but do not have hepatitis (neither acute nor chronic HBV), antiviral treatment is recommended prior to treatment with dostarlimab:\n    * if the HBV DNA level is ≥ 500 IU\u002FmL or 2,500 copies\u002FmL: antiviral treatment is recommended before starting dostarlimab and should be initiated within 3 weeks of starting immunotherapy or, at the latest, concomitantly. This treatment should continue for up to 12 months after the end of treatment with dostarlimab or any other immunosuppressive therapy.\n    * if the HBV DNA level is \\\u003C 500 IU\u002FmL or 2,500 copies\u002FmL: antiviral treatment is recommended before starting dostarlimab and should be initiated concurrently at the latest. This treatment should be continued for up to 12 months after the end of treatment with dostarlimab or any other immunosuppressive therapy.\n11. Has hepatitis C virus (HCV) prior to inclusion, Note: Patients positive for HCV antibody are eligible only if PCR testing is negative for HCV RNA.\n12. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his\u002Fher consent,\n13. Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness.\n\n    Non-eligible to immunotherapy:\n14. Has pyloric tumor, Note: tumors of the pylorus will be excluded because of the risk of high occlusion in case of pseudo progression and associated surgery,\n15. Has any history of autoimmune disease including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, Note: History of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n\n    Note: Controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.\n16. Has a history of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest imaging,\n17. Has received any live, attenuated vaccine within 14 days prior to the firs dose of study treatment or such administration is anticipated during the study,\n18. Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting CD137, CTLA-4, PD-1, or PD-L1 or other checkpoint pathways,\n19. Has had prior allogeneic bone marrow transplantation or prior solid organ transplantation,\n20. Has received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of adjuvant treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n\nNote: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled into the study after approval of Medical Contact. Note: Subjects are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses including doses \\>10 mg daily prednisone is permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.",{"count":5,"type":21},[24],"This phase II study evaluates dostarlimab followed by a watch-and-wait strategy in patients with localized dMMR\u002FMSI-H gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study aims to determine whether surgery can be safely avoided in patients achieving a complete response, defined by negative endoscopy and tumor-free biopsies after treatment.",[162,30],"Adenocarcinoma - GEJ",[164,165,166,167,168,169],"dMMR","MSI-H","dostarlimab","watch-and-wait","surgery","immunotherapy","2026-08-14",{"date":113,"type":35},{"date":173,"type":35},"2024-01-22",{"date":175,"type":21},"2028-09-01",{"name":177,"class":65},"GERCOR - Multidisciplinary Oncology Cooperative Group",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":66},"100442185","phase-1-magnetic-sentinel-lymph-node-mapping-in-gastric-cancer-100442185","NCT05038098","Magnetic Sentinel Lymph Node Mapping in Gastric Cancer","Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Willing to provide informed consent\n* Biopsy proven gastric cancer, undergoing curative-intent gastrectomy\n* No distant metastases\n* Pathologic diagnosis of gastric adenocarcinoma\n* Pre-treatment endoscopic measurement of less than or equal to 4 cm in diameter of the gastric cancer\n\nExclusion Criteria:\n\n* Contraindications to surgery +\u002F- adjuvant therapy\n* Allergy or intolerance to iron oxide compounds\n* Allergy or intolerance to iodides\n* Iron overload disorder\n* Pregnant or lactating women\\*\n\n  * Use of contraception is required for females during the study. Male patients who are sexually active with a female of childbearing potential are allowed for study enrollment and will not require use of contraception",{"count":186,"type":21},20,[99],"This phase I finds out the possible benefits and\u002For side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.",[30],"2026-08-13",{"date":170,"type":35},{"date":193,"type":21},"2026-12-31",{"date":195,"type":21},"2027-02-02",{"name":197,"class":65},"M.D. Anderson Cancer Center",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":120},"100645544","phase-2-perioperative-hlx10-serplulimab-with-s-1oxaliplatin-sox-in-locally-advanced-and-pd-l1-positive-gastric-or-esophagogastric-junction-adenocarcinoma-100645544","NCT07699939","Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma","Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial","PLATANUS","Inclusion Criteria:\n\n* 1\\) Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma at the study site. (For gastroesophageal junction adenocarcinoma, only patients classified as Siewert type II or type III who do not require surgery involving simultaneous thoracoabdominal incision are eligible.)\n* 2\\) Tumor tissue determined to be PD-L1 positive (CPS \\>= 5) based on pre-screening evaluation by the central laboratory.\n* 3\\) Diagnosis of cT3-4N1-3M0 disease according to the AJCC\u002FUICC-TNM 8th edition based on assessments performed within 28 days prior to randomization (the same day of the week 4 weeks before the randomization date is acceptable; the same applies hereafter), with no prior systemic treatment. Pre-randomization laparoscopy is not mandatory, but if performed, no non-curative factors (including liver metastasis, peritoneal metastasis, other distant metastases, or positive peritoneal cytology (CY1)) should be observed.\n* 4\\) Judged by the investigator as capable of undergoing R0 resection.\n* 5\\) Age between 18 years and 80 years on the day of enrollment.\n* 6\\) ECOG performance status (PS) of 0 or 1.\n* 7\\) The most recent laboratory values obtained within 14 days prior to randomization meet all of the following (however, transfusion, recombinant human thrombopoietin, and administration of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to blood collection are not permitted): (1) Neutrophil count \\>= 1500\u002Fmm\\^3 (2) Hemoglobin \\>= 9.0 g\u002FdL (3) Platelet count \\>= 10 x 10\\^4\u002Fmm\\^3 (4) Total bilirubin \\\u003C= 1.5 mg\u002FdL (5) AST \\\u003C= 100 U\u002FL (6) ALT \\\u003C= 100 U\u002FL (7) Serum albumin \\>= 3.0 g\u002FdL (8) Serum creatinine \\\u003C= 1.5 mg\u002FdL (9) APTT \\\u003C= 60 s (10) PT-INR \\\u003C= 1.5\n* 8\\) Females of childbearing potential should test negative for pregnancy test (serum or urine) within 7 days prior to randomization (the same day of the week is acceptable).\n* 9\\) Male patients and females of childbearing potential agree to use contraception from the time of provision of informed consent through a specified period after the last administration of study treatment (until at least 120 days after the last dose of HLX10 and at least 180 days after the last dose of study drug other than HLX10 (S-1 or oxaliplatin)).\n* 10\\) Written informed consent for study participation has been obtained from the patient.\n\nExclusion Criteria:\n\n* 1\\) Presence of another active malignancy within 5 years prior to enrollment or concurrently. Patients with cured, localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, non-invasive prostate cancer, non-invasive cervical cancer, and non-invasive breast cancer are permitted.\n* 2\\) Patients scheduled to undergo organ transplantation or bone marrow transplantation.\n* 3\\) Myocardial infarction and\u002For uncontrolled arrhythmia (including QTc interval \\>= 450 ms in males or \\>= 470 ms in females) occurring within 6 months prior to randomization (QTc interval calculated using Fridericia's formula).\n* 4\\) Cardiac dysfunction classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \\\u003C 50 percent on echocardiography.\n* 5\\) Positive for any of the following: HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA is measured only if HCV antibody is positive).\n* 6\\) HBs antigen negative, HBs antibody and\u002For HBc antibody positive, and quantitative HBV-DNA detectable (patients are not excluded if HBV-DNA is below the limit of detection).\n* 7\\) Active tuberculosis.\n* 8\\) Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and\u002For severe pulmonary dysfunction that may interfere with evaluation and management of suspected drug-related pulmonary toxicity.\n* 9\\) Known active or suspected autoimmune disease, excluding patients whose disease is stable at randomization and who do not require systemic immunosuppressive therapy.\n* 10\\) Patients who received live vaccination within 28 days prior to randomization, except for inactivated virus vaccines used for seasonal influenza prophylaxis.\n* 11\\) Patients who require systemic corticosteroids (a therapeutic dose of \\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to randomization or during the study period. However, in the absence of active autoimmune disease, patients are permitted to use steroids at a dose of \\\u003C= 10 mg\u002Fday prednisone or equivalent, or inhaled steroids, or adrenal hormone replacement therapy.\n* 12\\) Patients who have an active infection requiring systemic anti-infective treatment within 14 days prior to randomization, except for prophylactic antibiotic treatment (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease).\n* 13\\) Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy.\n* 14\\) Patients currently receiving other clinical study treatment, or for whom the planned start of treatment in this study is \\\u003C 14 days from completion of the prior clinical study treatment.\n* 15\\) History of severe hypersensitivity to the monoclonal antibody or any component of the study drug.\n* 16\\) History of psychotropic drug abuse or drug dependence.\n* 17\\) Patients with a disease that may increase the risk associated with study participation and use of the study drug, or with other severe acute or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the study.","80 Years",{"count":208,"type":21},136,[24],"To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.",[30,212],"Gastroesophageal Junction (GEJ) Adenocarcinoma",[214,215,216,217,218],"SOX regimen","PD-1 inhibitor","Perioperative chemotherapy","serplulimab","Immuno-chemotherapy","2026-08-04",{"date":221,"type":35},"2026-08-05",{"date":223,"type":35},"2026-07-15",{"date":225,"type":21},"2029-06-30",{"name":227,"class":228},"National Cancer Center, Japan","OTHER_GOV",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":253,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270","NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease",{"count":237,"type":21},260,[99],"This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[241,242,30,243,244,245,246,247,248,249,250,251,252],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Bladder Cancer","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[254,255,256,257,258,259,260,261,262,263,264,265,266,267,268],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","2026-08-03",{"date":221,"type":35},{"date":272,"type":35},"2026-03-04",{"date":274,"type":21},"2028-04-30",{"name":276,"class":42},"IDEAYA Biosciences",17,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":66},"100644673","phase-3-a-study-of-asp2138-together-with-chemotherapy-and-pembrolizumab-in-adults-with-gastric-cancer-100644673","NCT07673887","A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer","A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive","Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed gastric or GEJ adenocarcinoma.\n* Participant has radiographically confirmed, locally advanced unresectable or metastatic disease within 28 days prior to randomization.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a women of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum human chorionic gonadotropin (HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after the final administration of study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final administration of study intervention.\n* Male participant must not donate sperm during the treatment period and for 6 months after the final administration of study intervention.\n* Participant has radiologically evaluable disease (measurable and\u002For non measurable) according to RECIST V1.1, per investigator assessment, \\\u003C= 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy \\\u003C= 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\n* Participant's tumor is HER2-negative (HER2 immunohistochemistry (IHC) score 0+\u002F1+ or HER2 IHC score 2+\u002Fin situ hybridization (ISH) negative) as determined by local or central testing.\n* Participant has provided an formalin-fixed paraffin-embedded (FFPE) tumor sample which meets the requirements of the study as specified in the laboratory manual.\n* Participant has CLDN18.2-positive tumor as determined by central testing.\n* Participant has a valid programmed death-ligand 1 (PD-L1) result as determined by central testing of a tumor sample.\n* Participant with known microsatellite instability-high or mismatch repair deficient status may enroll as long as their tumor expresses PD-L1 combined positive score (CPS) \\>= 1 as determined by central IHC testing.\n* Participant has ECOG performance status 0 to 1.\n* Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used (transfusion is allowed, but posttransfusion hemoglobin \\[24 hours or later following transfusion\\] must be \\>= 9 g\u002FdL).\n\nSouth Korea Specific:\n\n* Participant is \\>= 19 years of age at the time of signing informed consent.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must not donate sperm during the treatment period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n\nJapan Specific:\n\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG and a demonstrated nonpregnant status through additional testing are eligible.)\n\nExclusion Criteria:\n\n* Participant has mixed histology or non-adenocarcinoma gastric or GEJ cancer.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to randomization.\n* Participant has gastrointestinal (GI) perforation, fistulae, untreated gastric ulcers that would preclude the participant from study participation, or any arterial thromboembolic event within 6 months, or any significant GI bleeding or any significant venous thromboembolism within 3 months prior to randomization.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has pre existing peripheral neuropathy \\> Grade 1.\n* Participant has poorly controlled hypertension.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.\n  * corrected QT (QTc) interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants.\n  * Documented history or family history of congenital long QT syndrome.\n  * Cardiac arrhythmias requiring anti-arrhythmic medications (Exception: Participant with rate-controlled atrial fibrillation for \\> 1 month prior to randomization is eligible), obligate use of cardiac pacemaker, or a history of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes).\n* Participant has a diagnosis of immunodeficiency or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Participants that require replacement therapy (e.g., thyroxine (T4), insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has history of another malignancy within 3 years prior to randomization, or any evidence of residual disease from a previously diagnosed malignancy. Participants with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance\u002Fwatchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with medications that affect the coagulation cascade with an international normalized ratio (INR) \\> 2 (e.g., vitamin K antagonists) is not allowed.\n* Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade \\>= 2 bleeding events 28 days prior to randomization).\n* Participant has uncontrolled intercurrent illness.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.\n* Participant is known to have human immunodeficiency virus (HIV) infection except for those with cluster of differentiation (CD) 4+ T cell counts \\>= 350 cells\u002Fmicroliter (µL) and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months are eligible. NOTE: Screening for HIV infection should be conducted if indicated per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted if indicated per local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core (HBc) antibody positive, an hepatitis B virus (HBV) DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of a positive test for tuberculosis or known active tuberculosis infection. NOTE: Screening for these infections should be conducted per local requirements.\n* Participant has known complete dihydropyrimidine dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).\n* Participant has pernicious anemia or other anemias due to vitamin B12 deficiency.\n* Participant has received prior systemic chemotherapy and\u002For immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, a maximum of 1 cycle of mFOLFOX6 or CAPOX with or without immunotherapy (for those participants with CPS \\>= 1) is allowed to be administered prior to randomization (Note: No dose modifications are allowed for the lead-in treatment). Participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy, or other systemic anticancer therapies as long as they were completed at least 6 months prior to randomization and there was disease progression occurs at least 6 months after the last dose. Participant may have received treatment with herbal medications that have known antitumor activity \\> 28 days prior to randomization. NOTE: Participants must have recovered from all AEs due to previous therapies to \\\u003C= Grade 1 or baseline.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids \\\u003C= 7 days prior to randomization. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.\n* Participant has had a major surgical procedure \\\u003C= 28 days before randomization and has not fully recovered.\n* Participant has received a CLDN18.2-targeted therapy \\\u003C= 28 days or 5 half-lives (whichever is longer) prior to randomization, or participant has experienced Grade \\>= 3 GI toxicity after receiving a CLDN18.2-targeted therapy.\n* Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma \\\u003C= 14 days prior to randomization and has NOT recovered from any related toxicity. A 7-day washout is permitted for palliative radiation (\\\u003C= 14 days duration time for radiotherapy) to non-CNS disease.\n* Participant has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\], OX-40, CD137) unless received in the perioperative setting.\n* Participant received a live or live-attenuated vaccine within 30 days prior to randomization. NOTE: Inactivated seasonal influenza vaccines are allowed.\n* Participant has received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to randomization or within 5 half-lives of the drug, whichever is shorter.\n* Participant has received any investigational therapy within 28 days prior to randomization or within 5 half-lives of the investigational medicinal product (IMP), whichever is longer.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n\nEU Specific:\n\n* Participant has known complete DPD deficiency (screening for DPD deficiency should be conducted per local requirements). All participants in the EU must be tested for DPD deficiency before receiving fluoropyrimidine-based chemotherapy, in accordance with European Society for Medical Oncology and European Medicines Agency (EMA) recommendations.",{"count":286,"type":21},570,[132],"Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system. It is also found in some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a type of immune cell called a T cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with gastric cancer (also known as stomach cancer) or gastroesophageal junction cancer (GEJ cancer). GEJ is where the tube that carries food (esophagus) joins the stomach.\n\nThis study is for people with gastric or GEJ cancer that has spread nearby (locally advanced) and is not removable by surgery (unresectable), or has spread to other parts of the body (metastatic). It is for those whose cancer is human epidermal growth factor receptor 2 (HER2)-negative and CLDN18.2-positive. HER2-negative means the cancer does not have extra HER2 protein, so medicines that target HER2 do not work and are therefore not used. CLDN18.2-positive means people have a certain amount of CLDN18.2 proteins on their cancer cells. In this study, researchers want to learn if ASP2138 given together with standard treatments (chemotherapy and pembrolizumab) help people with HER2-negative and CLDN18.2-positive gastric or GEJ cancer. The main aim is to learn how long people who are given ASP2138 with chemotherapy and pembrolizumab live without their cancer getting worse, compared with placebo given with chemotherapy with or without pembrolizumab, and if they live for longer. Placebo looks like the study treatment but does not have any medicine in it.\n\nThe main aim of this study is to check how well ASP2138 works when given together with chemotherapy and pembrolizumab compared with placebo plus chemotherapy with or without pembrolizumab.\n\nPeople aged 18 years or older with locally advanced unresectable or metastatic gastric or GEJ cancer can take part. Their tumor should be HER2-negative and CLDN18.2-positive. The study doctors will check people for any health conditions that can exclude them from taking part, interfere with the study procedures, or pose an unacceptable risk.\n\nThis is a double-blind study. That means the people and the study doctors will not know who will receive which treatment. People will be assigned to one of 2 treatment groups by chance:\n\nGroup A: People will receive ASP2138 along with chemotherapy and pembrolizumab. Group B: People will receive placebo along with chemotherapy, with or without pembrolizumab.\n\nPeople will keep receiving treatment until their cancer gets worse, they have medical problems that require stopping treatment, or a study rule says they must stop. There will be regular safety checks. People will continue to have scans of their tumor until their cancer becomes worse.",[30,212],[291,292,293,294],"Claudin (CLDN) 18.2","ASP2138","Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","2026-07-22",{"date":297,"type":35},"2026-07-23",{"date":299,"type":35},"2026-06-30",{"date":301,"type":21},"2031-02-28",{"name":303,"class":42},"Astellas Pharma Global Development, Inc.",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":313,"phases":4,"briefSummary":314,"conditions":315,"keywords":322,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100647926","breath-research-narrow-validation-for-gastrointestinal-cancer-detection-100647926","NCT07714538","Breath Research Narrow Validation for Gastrointestinal Cancer Detection","BRAVE","Inclusion Criteria:\n\nAdult participants ≥ 18 years old who meet at least one of the following criteria\n\nColorectal arm:\n\n1. Cancer: Histologically-confirmed CRC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings\n\nPancreatic arm:\n\n1. Cancer: Histologically-confirmed PDAC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal pancreas\n\nOesophagogastric arm:\n\n1. Cancer: Histologically-confirmed OGC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nOesophageal squamous arm:\n\n1. Cancer: Histologically-confirmed OSCC\\*\n2. Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings\n\nLiver arm:\n\n1. Cancer: Histologically- or radiologically-confirmed HCC or CCC\\*\n2. Control: Non-specific abdominal symptoms with a radiologically-normal liver\n\n   * Patients with suspected cancer (e.g. based on imaging) but who do not have histological confirmation prior to participating in the study may still be recruited and followed up to determine whether or not a diagnosis of cancer was subsequently confirmed.\n\nExclusion Criteria:\n\n* Patients who have already received chemotherapy, radiotherapy or surgery for their cancer\n* History of another cancer (other than non-melanoma skin cancers) within three years\n* Participants with co-morbidities preventing breath collection\n* Unable or unwilling to provide informed consent\n* (For Oesophagogastric arm only): Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n* (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days",{"count":312,"type":21},1000,"OBSERVATIONAL","The investigators of this study are developing a simple breath test to help detect gastrointestinal (gut) cancers earlier, including cancers of the oesophagus (food pipe), stomach, pancreas, liver and bowel. These cancers often cause non-specific symptoms that are similar to benign conditions, making early diagnosis difficult. Delays between the onset of symptoms and referral for a diagnostic test such as an endoscopy or a scan, can allow the cancer to progress.\n\nThe breath test detects small molecules called volatile organic compounds (VOCs) that are released in exhaled breath. Some of these VOCs are strongly associated with these cancers and may help identify high-risk patients who require urgent investigation.\n\nIn practice, patients who come to their GP with concerning symptoms will be offered the breath test. If the test is positive, patients can be referred promptly for a diagnostic test, while those with a negative result can be reassured and offered re-testing if symptoms persist. Earlier diagnosis could improve access to curative treatment while reducing unnecessary invasive investigations.\n\nPrevious studies have identified a panel of VOCs that appear to distinguish patients with gastrointestinal cancers from those without cancer. This study aims to confirm these findings in a new group of participants to determine whether the same biomarkers can be reliably identified.\n\nParticipants will provide a breath sample, usually before a hospital procedure they are already scheduled to undergo, and complete a short questionnaire about their medical history and medications. Some participants will also be asked to drink a nutritional supplement before providing a second breath sample. The results will help determine whether the breath test is reliable enough for further clinical evaluation",[316,317,30,318,319,320,321],"Oesophageal Squamous Cell Carcinoma","Oesophageal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Cholangiocarcinoma","Hepatocellular Carcinoma (HCC)","Colorectal Adenocarcinoma",[323,324,325,55,326,327,251],"Early Detection","Volatile Organic Compunds","Oesophageal Cancer","Colorectal Cancer","Liver Cancer","2026-07-21",{"date":297,"type":35},{"date":331,"type":21},"2026-07-20",{"date":333,"type":21},"2028-08-02",{"name":335,"class":65},"Imperial College London",6,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":357,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":66},"100614693","phase-2-trial-comparing-standard-of-care-therapy-with-and-without-sequential-cytoreductive-intervention-for-patients-with-metastatic-foregut-adenocarcinoma-and-undetectable-circulating-tumor-deoxyribose-nucleic-acid-ctdna-levels-100614693","NCT07282912","Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","OLIGOMETS","Inclusion Criteria:\n\n* Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.\n\n  a) All participants must have confirmed histologic diagnosis of the primary tumor, which may be confirmed retrospectively by a radiologist if necessary.\n* Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo\u002Fradioembolization (cholangiocarcinomas).\n* Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:\n\n  1. Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative radiation\u002Fablative therapy\n  2. Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments), wedge resection requiring a minimum of 40% of liver parenchyma following resection based on future liver remnant or a combination of partial hepatectomy and microwave ablation or trans-arterial radioembolization (TARE).\n  3. Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites) (see Appendix 3).\n  4. Resectable peritoneal disease with a PCI of ≤6 and the ability to obtain a CC0 cytoreduction.\n  5. Distant metastasis must be limited to two of the above-mentioned sites (a-d).\n  6. If both pulmonary and liver metastasis are present (a, b), then a total of five lesions will be considered oligometastatic.\n* Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.\n* Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.\n* Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.\n* Patients must have at least 4 months of prior effective systemic therapy.\n* Has hemoglobin ≥ 8 g\u002FdL.\n* Has ANC ≥ 1500\u002FuL.\n* Has platelet count ≥ 75000\u002FuL.\n* Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n* Has aspartate aminotransferase (AST) \\& alanine aminotransferase (ALT) ≤ 5 times ULN.\n* Has creatinine clearance ≥ 50 mL\u002Fmin.\n* Patient who is at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score 0-1 (see Appendix 6) at the time of randomization.\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence) during the treatment period and for at least 95 days following completion. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the participant may participate in the main study without participating in the FBR.\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nNote: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* Has developed progressive disease on current line of systemic therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past three years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known CNS metastasis and\u002For carcinomatous meningitis.\n* Has known osseous metastasis.\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.\n* Has histologic subtypes not included in the inclusion criteria (including esophageal squamous cell carcinoma, gastroenteropancreatic neuroendocrine tumors, hepatocellular carcinoma, etc.).\n* Has a primary tumor that is not amenable to the treatment modalities listed in section 3.\n* Has albumin level less than 3.0 g\u002FdL despite appropriate nutritional support. Diagnostic Assessments\n* Has detectable ctDNA at the time of enrollment.\n* Has an active infection requiring systemic therapy.\n* Has known active TB\u002FCOVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.\n* Inability to receive chemotherapy and\u002For surgery and\u002For radiotherapy and\u002For ablative procedures due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.",{"count":346,"type":21},54,[24],"This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.",[350,29,351,30,352,353,354,355,356],"Foregut Adenocarcinoma","Gastroesophageal Adenocarcinoma","Pancreas Adenocarcinoma","Duodenal Adenocarcinoma","Ampullary Adenocarcinoma","Gallbladder Adenocarcinoma","Intra - and Extrahepatic Cholangiocarcinoma",[358,359,360,361,362,363,364,365,366],"Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Oligometastasis","Esophageal adenocarcinoma","Gastroesophageal adenocarcinoma,","Gastric adenocarcinoma","Duodenal adenocarcinoma","Pancreatic\u002Fampullary adenocarcinoma","Gallbladder adenocarcinoma","Intra- and extrahepatic cholangiocarcinoma.","2026-07-17",{"date":328,"type":35},{"date":370,"type":35},"2026-06-02",{"date":372,"type":21},"2028-06",{"name":374,"class":65},"Yale University",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":66},"100628677","phase-2-shr-1701-with-or-without-apatinib-in-combination-with-chemotherapy-as-neoadjuvant-therapy-for-gastric-cancer-100628677","NCT07464756","SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer","A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study and provide signed informed consent;\n2. Age ≥18 years old;\n3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);\n4. Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable\n5. No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);\n6. Plan to proceed to surgery after completion of neoadjuvant therapy;\n7. Able to swallow tablets normally;\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n9. Estimated life expectancy ≥12 months;\n10. Has adequate organ function.\n11. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.\n\nExclusion Criteria:\n\n1. Known HER2 positive\n2. Need transthoracic surgical approach Based on the investigator's judgment\n3. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;\n\n5\\. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)",{"count":383,"type":21},80,[24],"This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.",[30],"2026-07-14",{"date":389,"type":35},"2026-07-16",{"date":391,"type":35},"2026-04-03",{"date":393,"type":21},"2030-07-31",{"name":395,"class":65},"The First Affiliated Hospital with Nanjing Medical University",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":419},"100467347","phase-1-a-study-of-asp2138-given-by-itself-or-given-with-other-cancer-treatments-in-adults-with-stomach-cancer-gastroesophageal-junction-cancer-or-pancreatic-cancer-100467347","NCT05365581","A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer","A Phase 1\u002F1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria (IC):\n\n* Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).\n* Female participant is not pregnant, confirmed by serum pregnancy test \\&vmedical evaluation by interview \\& at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Female participant must not donate ova starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant must not donate sperm during the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period \\& for 6 months after the final study intervention administration.\n* Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.\n* Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.\n* Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has QT interval by Fredericia (QTcF) =\\\u003C 470 msec.\n* Participant agrees not to participate in another interventional study while receiving study Intervention in the present study.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>= 1 week after any blood transfusion.\n\nMonotherapy Disease specific Criteria (MDSC): Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed metastatic, locally advanced unresectable gastric\u002Fgastroesophageal junction (GEJ) adenocarcinoma.\n* Escalation: Participant with gastric\u002FGEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with gastric\u002FGEJ adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.\n\n  * Unique to EU: Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received at least first-line standard therapies in the metastatic setting, must have received ramucirumab treatment if eligible \\& where ramucirumab is available, \\& no more than 3 prior lines of systemic chemotherapy treatment.\n\nMDSC: Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.\n* Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.\n\nNote: Participants with locally advanced unresectable pancreatic adenocarcinoma will not be admitted in monotherapy arms.\n\n* Unique to EU: Participant with pancreatic adenocarcinoma must have received at least first-line standard therapies in the metastatic setting \\& no more than 2 prior lines of systemic chemotherapy treatment.\n\nFor all participants in combination therapy (CT) administration:\n\n* If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCombination Therapy Disease-specific (CTDS) IC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma has progressed \\& must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nUnique to EU:\n\n* Participant must have a PD-L1 CPS ≥ 1.\n\nCTDS IC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression after first line platinum \\& fluoropyrimidine treatment in the metastatic setting or disease progression during or within 4 months of the last dose of perioperative treatment.\n* For combination therapy with paclitaxel, female participant must follow contraception guidelines from time of informed consent through at least 7 months after final study intervention.\n\nCTDS IC: ASP2138 in Combination with mFOLFIRINOX as First-line Therapy in Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.\n* Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.\n* Participant has pancreatic adenocarcinoma, has progressed \\& must not have received prior systemic anticancer therapy for their advanced disease. However, participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as they were completed at least 6 months prior to enrollment and without disease progression or recurrence.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n\\- If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCTDS IC: ASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participants have a HER2-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\nExclusion Criteria (EC):\n\n* Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.\n* Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.\n* Participant weighs \\\u003C 40 kg.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has significant gastric bleeding \\&\u002For untreated gastric ulcers that exclude the participant from participation.\n* Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable \\& have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention \\& are not requiring immunosuppressive doses of systemic steroids (\\> 10 mg per day of prednisone or equivalent) for longer than 2 weeks.\n* Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts \\>= 350 cells\u002FµL \\& no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus deoxyribonucleic acid test will be performed \\& if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.\n  * Participant treated for HCV with undetectable viral load results are eligible\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has had a major surgical procedure 28 days before start of study intervention \\& has not fully recovered.\n* Participant has received radiotherapy metastatic or for locally advanced unresectable gastric\u002FGEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention \\& has NOT recovered from any related toxicity.\n* Participant has another malignancy for which treatment is required.\n* Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose escalation cohorts. However, a participant who has received CLDN18.2-targeted therapy greater than 28 days or 5 half-lives (whichever is longer) prior to first dose study intervention administration is eligible for dose expansion cohorts only, with the exception of participants who have experienced Grade \\>= 3 gastrointestinal toxicity after receiving an CLDN18.2-targeted therapy.\n* Participant has a history or complication of interstitial lung disease.\n\nChina Specific:\n\nParticipant who has received treatment with herbal medications that have known antitumor activity within 28 days prior to first dose of study treatment.\n\nFor all participants in CT administration:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& mFOLFOX6 \\[all components\\], ramucirumab \\& paclitaxel or mFOLFIRINOX \\[all components\\]).\n* For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FµL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention (Unique to EU: high blood pressure Stage 2 is defined as ≥ 140\u002F90 mmHg).\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n\nCTDS EC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n\nCTDS EC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer:\n\n* History of cerebrovascular accident or transient ischemic attack within 6 months prior to study intervention.\n* Participant has significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study intervention.\n* Participant has evidence of a bleeding diathesis or significant coagulopathy.\n* Participant has initiated new treatment with medications that affect the coagulation cascade with an INR ≥ 2 such as vitamin K antagonists, heparins \\& direct thrombin inhibitors or the use of factor Xa inhibitors within 28 days prior to the start of study intervention.\n\nNote: If the participant started receiving such medications more than 28 days prior to the start of study intervention \\& needs to continue, this is allowed. However, new anticoagulation medications may not be initiated within 28 days prior to the start of study intervention.\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& CAPOX \\[all components\\]).\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded, however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FμL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n* Participant has known DPD deficiency.\n\nCTDS EC:\n\nASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (noninfectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Participants who require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.",{"count":404,"type":21},398,[99],"Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments.\n\nThe main aims of the study are:\n\n* To check the safety of ASP2138 and how well people can tolerate medical problems during the study.\n* To find a suitable dose of ASP2138 to be used later in the study.\n* These are done for ASP2138 given by itself and when given together with the standard cancer treatments.\n\nAdults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a \"trigger\" such as infection, or have a specific heart condition (\"New York Heart Association Class III or IV\").\n\nPhase 1: Lower to higher doses of ASP2138\n\n* ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection).\n* Different small groups are given lower to higher doses of ASAP2138.\n* ASP2138 is either given by itself, or given with 1 of 3 standard treatments:\n* Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer)\n* Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer)\n* ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer)\n\nPhase 1b: doses of ASP2138 worked out from Phase 1\n\n* ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1.\n* People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1.\n* This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments.\n* The standard cancer treatments given depends on the type of cancer they have.\n\nEnd of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment.\n\nPeople who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.",[30,212,408],"Pancreatic Adenocarcinoma",[291,292,410,411,412],"Pharmacokinetics","Safety","Tolerability",{"date":223,"type":35},{"date":415,"type":35},"2022-06-07",{"date":417,"type":21},"2028-05-31",{"name":303,"class":42},46,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":4},"100647747","phase-2-conversion-therapy-with-retlirafusp-alfa-plus-chemotherapy-in-gastric-or-gastroesophageal-junction-adenocarcinoma-100647747","NCT07709767","Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma","A Single-Arm, Exploratory Study of Retlirafusp Alfa Plus Chemotherapy as Conversion Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by gastroscopic biopsy.\n2. Potentially resectable gastric or gastroesophageal junction adenocarcinoma as judged by the investigator, including but not limited to: T4b disease or fixed\u002Ffused lymph nodes; single liver metastasis, limited para-aortic lymph node metastasis (No.16a2\u002Fb1), or CY1P0 disease; more than one liver metastasis or a liver metastasis larger than 5 cm adjacent to the hepatic vein or portal vein, extensive para-aortic lymph node metastasis (No.16a1\u002Fb2), or selected distant metastases such as Virchow lymph node or lung metastasis.\n3. HER2-low, HER2-intermediate, or HER2-negative disease, and PD-L1 CPS ≥1.\n4. Age 18 to 75 years.\n5. Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. No prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.\n7. Adequate organ function, defined as: white blood cell count ≥3.0 × 10\\^9\u002FL; absolute neutrophil count ≥1.5 × 10\\^9\u002FL; platelet count ≥100 × 10\\^9\u002FL; total bilirubin ≤ upper limit of normal; AST and ALT ≤3 × upper limit of normal; serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥50 mL\u002Fmin; activated partial thromboplastin time and international normalized ratio ≤1.5 × upper limit of normal; cardiac enzymes within normal range; and normal thyroid function. Participants with abnormal baseline TSH may be eligible if total T3 or free T3 and free T4 are within the normal range.\n8. Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and agree to use effective contraception during the study and for at least 3 months after the last dose. Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for at least 3 months after the last dose.\n9. Good compliance and willingness to complete study follow-up.\n\nExclusion Criteria:\n\n1. History of malignancy within 5 years or current presence of another malignancy.\n2. Prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.\n3. Macroscopically visible peritoneal metastasis or other unresectable distant metastasis.\n4. Active bleeding from the tumor as shown by endoscopy.\n5. Use of traditional Chinese medicine with antitumor indication or systemic immunomodulatory drugs, including thymosin, interferon, or interleukin, within 2 weeks before the first dose, except for local use to control pleural effusion.\n6. Requirement for systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday or other immunosuppressive therapy within 14 days before the first dose or during the study, except for topical or inhaled corticosteroids or adrenal replacement therapy at a dose equivalent to prednisone ≤10 mg\u002Fday in the absence of active autoimmune disease.\n7. Any active infection requiring systemic anti-infective therapy within 14 days before the first dose, except prophylactic antibiotics.\n8. Thrombotic events within 6 months before screening, including cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism, except catheter-related venous thrombosis that has resolved as judged by the investigator.\n9. Myocardial infarction or poorly controlled arrhythmia within 6 months before the first dose, including QTc interval ≥450 ms in males or ≥470 ms in females using Fridericia's formula.\n10. New York Heart Association class III or IV heart failure or left ventricular ejection fraction \\\u003C50% by echocardiography.\n11. Known hypersensitivity to SHR-1701 or active ingredients or excipients of the chemotherapy drugs used in this study.\n12. Known history of human immunodeficiency virus infection.\n13. Untreated active hepatitis B, defined as HBsAg positivity with HBV DNA above the upper limit of normal at the study site.\n14. Receipt of a live vaccine within 30 days before the first dose.\n15. Active pulmonary tuberculosis.\n16. Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.\n17. Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.\n18. Poorly controlled diabetes mellitus, defined as fasting blood glucose \\>10 mmol\u002FL.\n19. Any medical history, disease, treatment, laboratory abnormality, or other condition that may interfere with study results, prevent full participation in the study, or pose additional risk as judged by the investigator.",{"count":428,"type":21},21,[24],"This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.",[30,80],[433,434,435,436,55,80,437],"Retlirafusp Alfa","SHR-1701","CAPOX","Conversion Therapy","R0 Resection","2026-07-09",{"date":367,"type":35},{"date":441,"type":21},"2026-08-30",{"date":443,"type":21},"2032-08-30",{"name":445,"class":65},"Tang-Du Hospital",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":66},"100645435","phase-2-sacituzumab-tirumotecan-sac-tmtskb264-plus-tagitanlimab-kl-a167-in-patients-with-recurrent-or-metastatic-esophageal-squamous-cell-carcinoma-and-gastricgastroesophageal-junction-adenocarcinoma-100645435","NCT07701681","Sacituzumab Tirumotecan (Sac-TMT\u002FSKB264) Plus Tagitanlimab (KL-A167) in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric\u002FGastroesophageal Junction Adenocarcinoma","A Single-Arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT\u002FSKB264) Combined With Tagitanlimab (KL-A167) as Second-Line Therapy for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Aged ≥18 years at the time of signing the informed consent form;\n* Histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) or gastric\u002Fgastroesophageal junction (GEJ) adenocarcinoma;\n* Esophageal squamous cell carcinoma (ESCC) and gastric\u002Fgastroesophageal junction (GEJ) adenocarcinoma with disease progression following first-line anti-PD-1 combined chemotherapy, and the progression-free survival (PFS) of first-line treatment ≥3 months;\n* Radical concurrent chemoradiotherapy, neoadjuvant or adjuvant therapy: disease progression occurring during treatment or within 6 months after treatment discontinuation shall be deemed failure of first-line treatment.\n\n(Note: This also includes patients with advanced or recurrent non-target lesions who experience re-progression after radiotherapy alone. The criteria also apply to patients receiving palliative treatment for local (non-target) lesions for more than 2 weeks.)\n\n* Patients with HER2-positive gastric\u002Fgastroesophageal junction adenocarcinoma must have received prior anti-HER2 therapy;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first administration of study treatment;\n* Expected survival ≥3 months;\n* At least one measurable lesion per RECIST v1.1; lesions previously irradiated shall not be selected as target lesions; subjects with only skin lesions or bone lesions are not eligible for enrollment;\n* Participants must have recovered from all toxicities related to prior treatments (i.e., improved to Grade 0 or Grade 1, or met the levels specified in the eligibility criteria), except for toxicities not considered a safety risk (e.g., alopecia, vitiligo, and other asymptomatic laboratory abnormalities);\n* Adequate organ function defined as follows:\n\n  1. Hematology (no blood transfusion or hematopoietic stimulating agents for correction within 14 days): hemoglobin (Hb) ≥9 g\u002FdL; absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥100×10⁹\u002FL; neutrophil count (NEUT#) ≥1.5×10⁹\u002FL;\n  2. Serum total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5 × ULN.\n\n     For subjects with liver metastases: ALT and AST ≤5 × ULN, serum bilirubin ≤2 × ULN.\n\n     For subjects with liver and\u002For bone metastases: ALP ≤5 × ULN; serum albumin ≥30 g\u002FL;\n  3. Renal function: creatinine clearance (Ccr) ≥50 mL\u002Fmin;\n  4. Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5 × ULN.\n* Female participants of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraceptive measures from the date of signing the informed consent form until 6 months after the last study drug administration (see Appendix 2 for details);\n* Participants must voluntarily participate in this study, sign the informed consent form, and demonstrate good treatment compliance and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n* Participants diagnosed with other malignant tumors within 3 years prior to study drug administration, except for tumors cured by local therapy (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, cervical carcinoma in situ, etc.);\n* Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For spinal cord compression, or active central nervous system (CNS) metastases without prior local treatment. Participants with previously locally treated brain metastases may be enrolled if they remain clinically stable for at least 4 weeks prior to the first dose and do not require corticosteroids or anticonvulsants for a minimum of 14 days;\n* Participants with clinically significant cardiovascular diseases, including:\n\n  1. Severe or uncontrolled cardiac disorders or clinical symptoms requiring treatment within 6 months before the first study dose, including New York Heart Association (NYHA) Class III or IV congestive heart failure, drug-refractory unstable angina, severe arrhythmias requiring pharmacotherapy (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction;\n  2. Prior history of myocarditis or cardiomyopathy;\n  3. QTc interval \\>480 ms at baseline measurement;\n* Participants with severe and\u002For uncontrolled concomitant diseases, such as decompensated cirrhosis, nephrotic syndrome, poorly controlled hypertension, symptomatic pleural\u002Fpericardial effusion or ascites requiring repeated drainage;\n* Participants diagnosed with active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive, with HBV-DNA ≥ 500 IU\u002FmL or above the lower limit of quantification, whichever is higher\\] or hepatitis C (positive anti-HCV antibody with HCV-RNA above the lower limit of quantification);\n* Participants with poorly controlled known human immunodeficiency virus (HIV) infection, including HIV-infected individuals with a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease;\n* Participants with known active tuberculosis;\n* Participants with documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal disorders that hinder or delay corneal wound healing;\n* Participants who have undergone major surgery (as defined by the investigator) within 30 days before the first study dose or are still recovering from prior surgery;\n* Participants with known allergy or hypersensitivity to the study drug or its excipients, or a prior history of severe hypersensitivity reactions to monoclonal antibodies;\n* Participants with a history of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD\u002Fpneumonia, or suspected ILD\u002Fpneumonia that cannot be ruled out by imaging at screening;\n* Participants with a history of allogeneic tissue or organ transplantation; Autoimmune diseases requiring systemic therapy within the past 2 years or anticipated immunosuppressive therapy during the study period. Participants with well-controlled type 1 diabetes, euthyroid thyroiditis, hypothyroidism adequately managed via hormone replacement therapy (HRT), or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis) are eligible for enrollment;\n* Prior treatment with TROP2-targeted agents or any topoisomerase I inhibitors, including antibody-drug conjugates (ADCs);\n* Prior administration of any investigational anti-tumor vaccines or any agents targeting T-cell co-stimulatory pathways;\n* Vaccination with live vaccines within 30 days before the first study dose, or planned live vaccine administration during the study period;\n* Participants requiring strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose and throughout the study period. Concomitant use of strong CYP3A4 inhibitors or inducers is prohibited in this study; representative agents are listed in Appendix 7. All participants shall avoid concomitant use of any known CYP3A4-inducing medications, herbal supplements, and\u002For relevant foods to the greatest extent possible;\n* Receipt of any chemotherapy, radiotherapy, immunotherapy or biotherapy within 4 weeks before the first study dose; receipt of small-molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormonal therapy, systemic immune stimulants (including but not limited to interferon, IL-2), or proprietary Chinese herbal medicines approved for anti-tumor indications within 2 weeks before the first study dose;\n* Palliative radiotherapy administered to known metastatic sites within 2 weeks before the first study dose;\n* Systemic anti-infective therapy received within 1 week before the first study dose;\n* Female participants who are pregnant or breastfeeding;\n* Diseases requiring systemic corticosteroid therapy (prednisolone equivalent dose \\>10 mg\u002Fday) or other immunosuppressants within 14 days before the first study dose. Participants receiving intranasal, inhaled, topical cutaneous, local injectable corticosteroids (e.g., intra-articular injection), or corticosteroids for hypersensitivity prophylaxis may be enrolled;\n* Any other conditions under which the investigator deems the participant unsuitable for participation in this study.",{"count":454,"type":21},75,[24],"This is a single-arm, multi-center phase II study to evaluate the efficacy and safety of sacituzumab tirumotecan (Sac-TMT\u002FSKB264) combined with tagitanlimab (KL-A167) as 2nd line therapy for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) or gastric\u002Fgastroesophageal junction adenocarcinoma (G\u002FGEJA). A total of 75 participants are planned to be enrolled with 10 in the safety lead-in phase and 33 ESCC and 42 G\u002FGEJA in expansion phase, seperately.",[103,30,80,458,459],"Esophageal Squamous Cell Carcinoma (ESCC)","GC\u002FGEJC","2026-07-08",{"date":387,"type":35},{"date":463,"type":21},"2026-08-31",{"date":465,"type":21},"2029-09-01",{"name":467,"class":65},"Sun Yat-sen University",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":4},"100646247","phase-2-sac-tmt-combined-with-fruquintinib-as-second-line-treatment-in-patients-with-advanced-gastricgastroesophageal-junction-adenocarcinoma-100646247","NCT07689292","Sac-TMT Combined With Fruquintinib as Second-Line Treatment in Patients With Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","SKB264-Fru-GA","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed metastatic or locally advanced adenocarcinoma of the gastric or gastroesophageal junction, unresectable;\n* Subjects who have failed first-line standard systemic therapy, or experienced disease progression or recurrence within 6 months after completion of adjuvant systemic therapy (HER2-positive subjects must have received prior anti-HER2 therapy);\n* Have at least one measurable lesion per RECIST v1.1, subjects with only cutaneous or bone lesions are not eligible for enrollment;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to study drug administration;\n* Estimated life expectancy \\> 12 weeks.\n* Adequate organ and bone marrow function (no transfusions, recombinant human thrombopoietin or colony-stimulating factor administered within 2 weeks prior to dosing), defined as follows:\n\n  1. Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹\u002FL; platelets (PLT) ≥ 80×10⁹\u002FL; hemoglobin ≥ 90 g\u002FL;\n  2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); for subjects with baseline liver metastases, ALT and AST ≤ 5 × ULN; albumin ≥ 30 g\u002FL; total bilirubin (TBIL) ≤ 1.5 × ULN;\n  3. Renal function: Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula);\n  4. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5 × ULN.\n* All acute toxicities from prior treatments have recovered to Grade 1 or lower (alopecia and vitiligo are excluded). Note: Subjects with any grade of prior endocrine adverse events may be enrolled if they only require maintenance hormone replacement therapy and are stable and asymptomatic at screening.\n* Females of childbearing potential and males with partners of childbearing potential must agree to use effective medical contraception from the time of informed consent signature through 6 months after the last dose of study drug;\n* The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with protocol-specified study visits and related procedures.\n\nExclusion Criteria:\n\n* Participants unable to receive oral administration due to dysphagia, intractable vomiting, or known drug malabsorption;\n* Participants with active gastric\u002Fduodenal ulcer, ulcerative colitis, intestinal obstruction, or other gastrointestinal disorders\u002Fconditions judged by the Investigator to carry a risk of gastrointestinal hemorrhage or perforation; or with a history of intestinal perforation or fistula within the preceding 6 months; or with unresolved intestinal perforation\u002Ffistula following prior surgical repair;\n* Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For spinal cord compression, or active\u002Funtreated central nervous system (CNS) metastases. Participants with previously locally treated brain metastases may be enrolled if clinically stable for at least 4 weeks prior to dosing and not requiring corticosteroids or anticonvulsants for a minimum of 14 days before the first dose;\n* Participants diagnosed with another malignant tumor within 3 years prior to dosing, except malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.;\n* Participants with clinically significant cardiovascular disease, defined as:\n\n  1. Severe or uncontrolled cardiac disease or symptomatic cardiac conditions requiring treatment within 6 months prior to the first study dose, including congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, medically refractory unstable angina, severe arrhythmias requiring pharmacotherapy (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction;\n  2. Prior history of myocarditis or cardiomyopathy;\n  3. Baseline corrected QT (QTc) interval \\> 480 ms;\n* Participants with a history of arterial thromboembolism or deep vein thrombosis within the preceding 6 months;\n* Participants with documented or historical significant bleeding within 2 months prior to dosing, including melena, hematemesis, hemoptysis, ≥++ fecal occult blood. Subjects with 1+ fecal occult blood and underlying primary gastrointestinal lesions must complete gastroscopy prior to enrollment to rule out active bleeding or ulcers;\n* Participants with a history of stroke and\u002For transient ischemic attack (TIA) within 12 months prior to dosing;\n* Participants with severe and\u002For uncontrolled systemic diseases, such as unregulated metabolic disorders, active inflammatory bowel disease, or gastrointestinal perforation;\n* Participants with active hepatitis B \\[hepatitis B surface antigen (HBsAg)-positive, with HBV-DNA ≥1000 IU\u002FmL or above the lower limit of quantification (LLOQ), whichever is higher\\] or hepatitis C (hepatitis C antibody-positive with HCV-RNA above the LLOQ). Note: HBsAg-positive subjects must receive anti-HBV antiviral therapy throughout study treatment;\n* Participants with known poorly controlled human immunodeficiency virus (HIV) infection; subjects with active syphilis infection;\n* Participants with known active pulmonary tuberculosis;\n* Participants who have undergone major surgery (as defined by the Investigator) within 30 days prior to the first study dose, or are still in the postoperative recovery phase from prior surgery;\n* Participants with a history of severe hypersensitivity reactions to the study drug (including its excipients);\n* Participants with a history of non-infectious interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out via imaging at screening;\n* Participants with a history of allogeneic tissue\u002Forgan transplantation;\n* Participants previously treated with any of the following regimens (including adjuvant or neoadjuvant settings):\n\n  1. TROP2-targeted therapy;\n  2. Any therapy containing topoisomerase I inhibitors, including antibody-drug conjugates (ADCs);\n  3. Systemic therapy targeting the vascular endothelial growth factor receptor (VEGFR) signaling pathway;\n* Participants who received live vaccines within 30 days prior to dosing, or plan to receive live vaccines during the study period;\n* Participants requiring strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks before the first dose and throughout the study;\n* Participants who received chemotherapy, radiotherapy, immunotherapy, or biotherapy within 4 weeks before the first study dose;\n* Participants who received small-molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormonal therapy, systemic immune stimulants (including but not limited to interferon, IL-2), or proprietary Chinese medicines with approved anti-tumor indications within 2 weeks before the first study dose;\n* Participants with active infection requiring systemic anti-infective therapy within 2 weeks prior to dosing;\n* Participants with any disease requiring systemic corticosteroids (\\>10 mg prednisone equivalent daily) or other immunosuppressants within 14 days before the first study drug administration. Nasal, inhaled, topical, intra-articular corticosteroids, and corticosteroids administered for prophylaxis of infusion reactions are permitted;\n* Participants with documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal disorders with a history of impaired\u002Fdelayed corneal wound healing;\n* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test prior to the first dose;\n* Participants with urine protein ≥2+ and 24-hour urinary protein \\>1 g; or with uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);\n* Any other condition that, in the Investigator's judgment, renders the subject unsuitable for participation in this study.",{"count":477,"type":21},45,[24],"This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.",[30,212,481],"Gastro-esophageal Junction Adenocarcinoma","2026-07-07",{"date":438,"type":35},{"date":485,"type":21},"2026-07-31",{"date":487,"type":21},"2028-12-31",{"name":489,"class":65},"Tianjin Medical University Cancer Institute and Hospital",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":510,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":66},"100633678","phase-1-phase-12-study-of-bhb810-in-advanced-gastric-and-gej-adenocarcinoma-100633678","NCT07529808","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.",{"count":498,"type":21},164,[99,24],"This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",[55,30,502,351,242,212,503,504,505,506,507,251,508,509],"Gastric (Stomach) Cancer","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Gastrointestinal Cancers","Colorectal (Colon or Rectal) Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[511,512,513],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","2026-07-06",{"date":460,"type":35},{"date":517,"type":21},"2026-07",{"date":519,"type":21},"2028-12",{"name":521,"class":42},"BigHat Biosciences, Inc.",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":550},"100525561","phase-2-a-study-of-pembrolizumab-with-trastuzumab-and-chemotherapy-in-people-with-esophagogastric-cancer-100525561","NCT06123338","A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer","A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors","Inclusion Criteria:\n\n* Age 18 years or older at time of signing informed consent.\n* ECOG performance status 0-1.\n* HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+\u002FFISH\\>2.0 expression.\n* Complete surgical resection of the primary tumor must be achievable\n* Demonstrate adequate organ function as defined in Table 1.\n\nTable 1 - Organ Function Requirements for Eligibility Hematological\n\n* Absolute neutrophil count (ANC): ≥1,500 \u002FmcL\n* Platelets: ≥100,000 \u002F mcL\n* Hemoglobin: ≥8 g\u002FdL Renal\n* Creatinine clearance: ≥ 50 mL\u002Fminute Hepatic\n* Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)\n* AST and ALT: ≤ 2.5 X ULN\n* Albumin: \\>3 mg\u002FdL Coagulation\n* International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): \\\u003C1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Male participants: A male participant must agree to use contraception as detailed in Section 15.3 of this protocol during the treatment period and for at least 230 days (5 terminal half-lives of trastuzumab \\[140\\] plus an additional 90 days \\[spermatogenesis cycle\\]) after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR\n  2. A WOCBP who agrees to follow the contraceptive guidance in section 15.3 during the treatment period and for at least 170 days (140 days plus an additional 30 days \\[menstruation cycle\\]) after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease.\n* Has received prior treatment for esophagogastric cancer\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.\n* Has received prior therapy with an anti-HER2 agent\n* Left ventricular ejection fraction \\\u003C50% within 1 month of screening by MUGA or echocardiogram. Patients with an ejection fraction 45-49% may be permissible in the absence of any cardiac symptoms, if cleared by a cardiologist, and per the investigator's discresion.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.\n* Has a known history of active TB (Bacillus tuberculosis)\n* Hypersensitivity to pembrolizumab or any of its excipients\n* Has been diagnosed or treated for another malignancy in the past 3 years (not including non-melanoma skin cancer)\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has had an allogeneic tissue or solid organ transplant\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:\n\n  * Subjects with vitiligo or alopecia\n  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.\n  * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Is unwilling to give written informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study.",{"count":530,"type":21},49,[24],"The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.",[534,30,535],"Esophageal Cancer","HER2 Gene Mutation",[537,534,30,538,539,540,541,542,543],"HER2+ Esophageal cancer","HER2+ GEJ cancer","HER2 IHC3+ expression","IHC 2+\u002FFISH>2.0 expression","Esophagogastric cancer","Memorial Sloan Kettering Cancer Center","23-124",{"date":482,"type":35},{"date":546,"type":35},"2024-02-01",{"date":548,"type":21},"2027-11-30",{"name":542,"class":65},10,{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":313,"phases":4,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":4},"100646237","molecular-characterization-of-tumor-microenvironment-interactions-to-predict-drug-resistance-in-gastric-and-gej-adenocarcinoma-100646237","NCT07692477","Molecular Characterization of Tumor-Microenvironment Interactions to Predict Drug Resistance in Gastric and GEJ Adenocarcinoma","Molecular Characterization of Tumor-Microenvironment Interactions to Predict Drug Resistance to Perioperative Treatment in Patients With Gastric and Gastroesophageal Junction Adenocarcinoma","GASTROIMMUNE","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the stomach (gastric cancer, GC) or gastroesophageal junction (GEJ)\n2. Operable, locally advanced disease (T \\>= 2 and\u002For node-positive) according to AJCC 8th edition staging\n3. Candidate for perioperative chemotherapy with FLOT regimen combined with durvalumab, as per clinical practice\n4. Age \\>= 18 years\n5. Provision of written informed consent prior to any study-specific procedure\n\nExclusion Criteria:\n\n1. Presence of another active malignant disease\n2. Advanced or metastatic gastric\u002FGEJ cancer not eligible for surgical treatment\n3. Inability or unwillingness to provide written informed consent",{"count":560,"type":21},250,"Surgical resection remains the only curative option for resectable gastric cancer, but perioperative FLOT chemotherapy is associated with substantial rates of chemoresistance and recurrence, largely driven by marked tumor heterogeneity. Recent data from the MATTERHORN phase III trial have shown that adding durvalumab to perioperative FLOT improves pathological complete response and survival, supporting this combination as a new standard of care for resectable gastric and gastroesophageal junction adenocarcinoma.\n\nThis observational multicenter study aims to characterize angiogenic and immune profiles within the tumor microenvironment and peripheral blood, in order to identify cellular and molecular signatures associated with response or resistance to perioperative FLOT plus durvalumab. Longitudinal biospecimen collection (PBMCs, serum, plasma, endoscopic biopsies, surgical specimens) will be integrated with multiparametric flow cytometry, single-cell transcriptomics and TCR\u002FBCR sequencing, immunohistochemistry, pathomics and multiplex immunoassays, to provide mechanistic insights and potential predictive biomarkers.",[30,563],"Gastroesophageal Junction Adenocarcinoma (Siewert II-III)",[565,566,567,568,569,570,571],"tumor microenvironment","perioperative chemotherapy","FLOT","durvalumab","angiogenesis","single-cell RNA sequencing","biomarkers","2026-07-02",{"date":438,"type":35},{"date":575,"type":21},"2026-09-01",{"date":175,"type":21},{"name":578,"class":65},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":4},"100641601","phase-2-hipec-priming-followed-by-serplulimab-plus-soxxelox-in-locally-advanced-gastric-cancer-100641601","NCT07621484","HIPEC Priming Followed by Serplulimab Plus SOX\u002FXELOX in Locally Advanced Gastric Cancer","A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX\u002FXELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive); gender unrestricted.\n* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma via endoscopic biopsy.\n* Clinical stage cT3-4a (imaging evidence of tumor invasion into or penetration through the serosa), N+ (lymph node positive), M0 (no distant organ metastasis), based on the 8th Edition of the AJCC Staging Manual.\n* HER2-negative disease, defined as HER2 IHC 0 or 1+, or IHC 2+ with negative ISH.\n* Diagnostic laparoscopy confirms the absence of macroscopic peritoneal metastasis (P0) and negative peritoneal lavage cytology (CY0).\n* Adequate cardiac function, rendering the patient eligible for curative-intent resection. If clinically indicated, patients with underlying ischemic heart disease, valvular heart disease, or other severe cardiac conditions must undergo a preoperative cardiac evaluation by a cardiologist.\n* ECOG Performance Status (PS) score of 0 or 1 within 7 days prior to enrollment.\n* Anticipated survival time of ≥ 6 months.\n* Hepatitis B surface antigen (HBsAg) negative (-) and Hepatitis B core antibody (HBcAb) negative (-). If HBsAg is positive (+) or HBcAb is positive (+), the Hepatitis B virus DNA (HBV-DNA) level must be \\\u003C 1000 copies\u002FmL, \\\u003C 200 IU\u002FmL, or below the upper limit of normal (ULN) at the study center to be eligible for enrollment.\n* HCV antibody negative (-).\n* Major organ function is normal, defined as meeting the following criteria (having not received transfusions of blood products, albumin, recombinant human thrombopoietin, or colony-stimulating factors \\[CSF\\] within 14 days prior to randomization):\n\nHematologic System Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL Platelets (PLT) ≥ 100×10⁹\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Liver Function Total Bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Aspartate Aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Alkaline Phosphatase (ALP) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver and\u002For bone metastases Albumin ≥ 25 g\u002FL Renal Function Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) Coagulation Function Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN Prothrombin Time (PT) ≤ 1.5×ULN International Normalized Ratio (INR) ≤ 1.5×ULN -Female patients must meet the following criteria:\n\nBe in a postmenopausal state (defined as having had no menstruation for at least 1 year, with no other confirmed cause for amenorrhea other than menopause), or have undergone surgical sterilization (removal of ovaries and\u002For uterus); alternatively, patients with reproductive potential must simultaneously meet the following requirements:\n\n* A serum pregnancy test result must be negative within 7 days prior to randomization;\n* Agree to use a contraceptive method with an annual failure rate of \\\u003C 1% or practice abstinence (avoidance of heterosexual intercourse) (from the time of signing the informed consent form until at least 120 days after the last dose of the investigational drug, and at least 6 \\[months\\] after the last dose of the chemotherapy drug ...months (contraceptive methods with an annual failure rate of \\\u003C 1% include bilateral tubal ligation, vasectomy, correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices \\[IUDs\\], and copper-containing IUDs);\n* Must not be breastfeeding. -Male patients must meet the following criteria: Agree to practice abstinence (avoid heterosexual intercourse) or use contraception, as specified below: If the partner is a female of childbearing potential or is pregnant, the male patient must practice abstinence or correctly use condoms for contraception-to prevent drug exposure to the embryo-during the chemotherapy treatment period and for at least 6 months after the last dose of chemotherapy medication, and for at least 120 days after the last dose of the investigational drug. The reliability of sexual abstinence should be evaluated with reference to the duration of the clinical study, patient preference, and lifestyle. Periodic abstinence (e.g., calendar-based, ovulation-based, basal body temperature, or post-ovulation methods) and withdrawal (coitus interruptus) are not considered acceptable methods of contraception.\n\nExclusion Criteria:\n\n* History of other active malignancies within the past 5 years, or the presence of other active malignancies at the time of enrollment. Patients with cured localized tumors-such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, or carcinoma in situ of the breast-are eligible for enrollment.\n* Presence of documented distant metastases (e.g., liver, lung, or bone metastases) or laparoscopically confirmed peritoneal seeding (P1).\n* Patients scheduled to undergo, or with a history of having undergone, organ or bone marrow transplantation.\n* Occurrence of myocardial infarction or poorly controlled arrhythmias (including a QTc interval ≥ 450 ms for males or ≥ 470 ms for females; QTc interval calculated using the Fridericia formula) within 6 months prior to enrollment.\n* Presence of NYHA Class III or IV heart failure, or a cardiac ultrasound result showing a Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%.\n* Human Immunodeficiency Virus (HIV) infection.\n* Presence of active pulmonary tuberculosis.\n* History of, or current presence of, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe impairment of pulmonary function that could interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Presence of a known active or suspected autoimmune disease. Exceptions are made for patients whose disease is in a stable state at the time of enrollment (defined as requiring no systemic immunosuppressive therapy).\n* Receipt of a live vaccine within 28 days prior to enrollment; inactivated viral vaccines for seasonal influenza are permitted.\n* Patients requiring systemic corticosteroid therapy (at a prednisone-equivalent dose \\> 10 mg\u002Fday) or other immunosuppressive medications within 14 days prior to enrollment or during the study period. However, the following exceptions are permitted: in the absence of active autoimmune disease, patients may use topical or inhaled corticosteroids, or receive adrenal replacement therapy at a prednisone-equivalent dose ≤ 10 mg\u002Fday.\n* Presence of any active infection requiring systemic anti-infective treatment within 14 days prior to enrollment; prophylactic antibiotic treatment (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease) is an exception.\n* Prior receipt of any anti-tumor therapy for the current gastric cancer, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.\n* Currently receiving treatment in another clinical study, or the planned start date of the treatment in this study is less than 14 days after the completion of treatment in a previous clinical study.\n* Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug.\n* Known history of substance abuse (including drug abuse); patients who have ceased alcohol consumption are eligible for enrollment.\n* Presence of any condition that may increase the risks associated with study participation or the investigational drug, or presence of other severe, acute, or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the clinical study.",{"count":587,"type":21},48,[24],"Patients with locally advanced gastric cancer (LAGC), particularly those with serosal invasion, remain at high risk of peritoneal recurrence despite standard perioperative treatment. Hyperthermic intraperitoneal chemotherapy (HIPEC) may eradicate free intraperitoneal tumor cells and microscopic peritoneal disease while potentially enhancing systemic anti-tumor immune activation.\n\nThis is a prospective, single-center, single-arm exploratory study evaluating a HIPEC priming strategy followed by serplulimab-based neoadjuvant therapy in patients with locally advanced gastric cancer (cT3-4aN+M0). Eligible patients will undergo diagnostic laparoscopy confirming no visible peritoneal metastasis (P0) and negative peritoneal cytology (CY0), followed by docetaxel-based HIPEC.\n\nAfter recovery from HIPEC, patients will initially receive one cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX\u002FXELOX chemotherapy prior to radical gastrectomy.\n\nThe primary endpoints are pathological complete response (pCR) rate and major pathological response (MPR) rate. Secondary endpoints include R0 resection rate, objective response rate (ORR), peritoneal recurrence-free survival (PRFS), overall survival (OS), and safety.",[591,30,80],"Locally Advanced Gastric Cancer",[591,593,594,595],"HIPEC","Hyperthermic Intraperitoneal Chemotherapy","Peritoneal Recurrence",{"date":482,"type":35},{"date":598,"type":21},"2026-07-01",{"date":600,"type":21},"2028-05-09",{"name":602,"class":65},"Shanghai Changzheng Hospital",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":66},"100638663","phase-3-js107-in-combination-with-toripalimab-and-chemotherapy-for-the-treatment-of-cldn182-positive-gastric-or-gastroesophageal-junction-adenocarcinoma-100638663","NCT07584135","JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma","A Multicenter, Randomized, Controlled, Open-label Phase III Clinical Trial Evaluating the Efficacy and Safety of JS107 in Combination With Toripalimab and Chemotherapy Versus Sintilimab in Combination With Chemotherapy as First-line Treatment for CLDN18.2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria\n\n1. The patient voluntarily participated, provided informed consent, signed a written informed consent form, and had good compliance.\n2. Age ≥18 years (including), male and female. 3)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4）Expected survival period ≥3 months.\n\n5）Patients with HER2-negative, unresectable locally advanced, recurrent, or Metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histology\u002Fcytology. 6）Previously untreated for systemic therapy for locally advanced, recurrent, or Metastatic gastric\u002Fgastroesophageal junction (G\u002FGEJ) adenocarcinoma. 7）Positive for CLDN18.2 by IHC testing at the central laboratory. 8）According to the RECIST v1.1 criteria, the patient has ≥1 measurable lesion. 9）The functional level of the organ meets the requirements of the protocol. 10）Agree to use contraception during the study period; females of reproductive potential will undergo a blood pregnancy test within 7 days prior to randomization, with a negative result.\n\nExclusion Criteria:\n\n1. Previously received any drug or cell therapy targeting CLDN18.2\n2. Received major surgery, live vaccine administration, or Drug therapy with other investigational medicinal products, or received radiotherapy within 2 weeks prior to randomization.\n3. Imaging shows cerebral tumor lesions (unless whole-brain radiotherapy or surgery, etc., local treatment has been completed, and imaging and clinical stability have been assessed according to the protocol) 4)Peripheral neuropathy ≥ Grade 2\n\n5）Idiopathic pulmonary fibrosis, Organising pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computerised tomography (CT) scan 6）Pericardial effusion, Pleural effusion, or ascites with a large volume, or with clinical symptoms, or requiring symptomatic treatment.\n\n7）There is a need for systemic antimicrobial or antiviral therapy for active infection.\n\n8）Subjects who cannot take oral medications, require enteral nutrition to maintain feeding, or have Malabsorption syndrome or other conditions affecting gastrointestinal Malabsorption.\n\n9）Presence of biliary or gastrointestinal obstruction, or persistent recurrent vomiting 10）Weight loss of \\>10% within the previous 2 months or severe Malnutrition, known prior to randomization.\n\n11）History of gastrointestinal perforation and\u002For fistula within the prior 6 months; presence of high-risk Haemorrhage of digestive tract disease or risk of rupture bleeding or gastrointestinal\u002Frespiratory fistula 12）Serious cardiovascular and cerebrovascular diseases 13）History of systemic treatment for autoimmune diseases within the past 2 years 14）Randomly selected patients with any other Neoplasm malignant within the past 5 years.\n\n15）Known severe allergic reaction to any ingredient in the study drug formulation 16）Known active Hepatitis B, active Hepatitis C, human immunodeficiency (HIV) infection, or have undergone allogeneic stem cell or Solid organ transplant.\n\n17）Diseases determined by researchers to be unsuitable for participation.",{"count":611,"type":21},600,[132],"This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G\u002FGEJ adenocarcinoma.\n\nThe research subjects were patients with unresectable locally advanced, recurrent or metastatic G\u002FGEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant\u002Fadjuvant therapy that occurred more than 6 months after disease progression\u002Frecurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.",[30],"2026-06-25",{"date":617,"type":35},"2026-06-29",{"date":619,"type":35},"2026-05-28",{"date":621,"type":21},"2029-12-31",{"name":623,"class":42},"NingBo Junyan Hongshi Biosciences Co., Ltd",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":22,"phases":633,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":646,"locationsCount":648},"100519056","phase-2-a-study-of-trk-950-when-used-in-combination-with-ramucirumab-and-paclitaxel-in-patients-with-gastric-cancer-100519056","NCT06038578","A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.\n* The patient is eligible to receive Ramucirumab + Paclitaxel.\n* Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and\u002For cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:\n\n  1. First treatment for metastatic disease or locally advanced disease without experiencing adjuvant \u002F neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment\n  2. Adjuvant \u002F neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment\n  3. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment\n  4. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment\n* Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.\n* Signed, written IRB-approved informed consent.\n* Adequate organ function from specimens collected within 14 days prior to Day 1.\n* For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.\n* All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.\n\nExclusion Criteria:\n\n* Prior history of treatment with ramucirumab or paclitaxel.\n* HER2 positive gastric or GEJ adenocarcinoma.\n* Major surgery within 28 days prior to randomization.\n* Baseline corrected QT (QTc) interval of \\> 470 msec for females and \\> 450 msec for males calculated using Fridericia's formula.\n* New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.\n* The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.\n* The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)\n* Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).\n* The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.\n* Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.\n* History of gastrointestinal perforation and\u002For fistulae within 6 months prior to randomization.\n* The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.\n* The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.\n* The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.",{"count":632,"type":21},146,[24],"This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.",[30,55,80],[637,80,638,639],"Gastric Cancer, Adenocarcinoma","TRK-950","CAPRIN-1","2026-06-18",{"date":642,"type":35},"2026-06-23",{"date":644,"type":35},"2023-10-04",{"date":299,"type":21},{"name":647,"class":42},"Toray Industries, Inc",27,{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":22,"phases":658,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":66},"100374067","phase-2-oxaliplatin-and-liposomal-irinotecan-plus-trastuzumab-for-her2-positive-disease-in-advanced-esophageal-and-gastric-adenocarcinoma-100374067","NCT04150640","Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma","Phase 2 Trial of 5-Fluorouracil, Oxaliplatin and Liposomal Irinotecan and Immunotherapy (Plus Trastuzumab for HER2-positive Disease) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information.\n\nNOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS status prior to treatment initiation.\n* Measurable disease according to RECIST v1.1.\n* No prior lines of systemic therapy for advanced disease.\n* Participants who had received neoadjuvant or adjuvant therapy or definitive chemoradiation will be allowed to participate if recurrence occurred 6 months or longer from the completion of all prior treatments.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to registration\n\n  * Absolute Neutrophil Count (ANC) ≥1,500 \u002Fμl without the use of hematopoietic growth factors\n  * Hemoglobin (Hgb) ≥8 g\u002FdL (blood transfusions are permitted for participants with hemoglobin levels below 8 g\u002FdL)\n  * Platelets ≥100,000 \u002Fμl\n  * Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl calculation using the Cockcroft-Gault formula. ≥50 mL\u002Fmin for participants with creatinine levels \\> 1.5 X institutional ULN\n  * Bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); abnormal bilirubin (≤1·5 × upper limit of normal (ULN)) is allowed for patients with Gilbert's disease\n  * Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Women of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n* Women of childbearing potential and males must be willing to abstain from heterosexual activity or to use a form of effective method of contraception from the time of informed consent until 30 days after treatment discontinuation.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products.\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrollment).\n* Other active malignancy requiring treatment within the last 2 years. Exceptions include subjects with non-melanoma skin cancer, non-invasive\u002Fin situ cancer or low-risk prostate cancer requiring hormonal therapy only.\n* Current therapy with other investigational agents or participation in another clinical study (supportive care and nontherapeutic trial participation allowed if not receiving an investigational drug). Participants may participate in prescreening for other therapeutic trials (prescreening of biologic sample for specific mutations, receptors, etc.)\n* Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement).\n* Radiotherapy less than 7 days prior to the start of the study treatment\n* Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should not have any contraindications to immune checkpoint inhibitors and should not have received immunotherapy agents for the treatment of EGA prior to study enrollment.\n\n  * Participants must not have active autoimmune disease that has required systemic treatment in the past 2 years. Participants are permitted to receive immunotherapy l if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).\n  * Participants must not have a condition requiring systemic treatment with either corticosteroids (\\>10 mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of study immunotherapy administration. Inhaled or topical steroids and adrenal replacement doses (≤10 mg\u002Fday prednisone equivalent) are permitted. Participants with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents.\n* Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Active infection requiring systemic therapy.\n* Pregnant or breastfeeding.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.\n* Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.\n* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.\n* Known history of Human Immunodeficiency Virus (HIV).",{"count":657,"type":21},52,[24],"This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.",[29,30],{"date":642,"type":35},{"date":663,"type":35},"2020-07-13",{"date":665,"type":21},"2028-05",{"name":667,"class":65},"University of Wisconsin, Madison",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":22,"phases":677,"briefSummary":678,"conditions":679,"keywords":684,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":66},"100371266","phase-2-anti-pd-1-mab-plus-metabolic-modulator-in-solid-tumor-malignancies-100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":676,"type":21},72,[24],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[680,106,681,682,30,102,29,683],"Melanoma","Hepatocellular Carcinoma","Urothelial Cancer","Microsatellite Instability-High Solid Malignant Tumor",[685,686],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)",{"date":642,"type":35},{"date":689,"type":35},"2020-09-14",{"date":691,"type":21},"2032-04-30",{"name":693,"class":65},"Dan Zandberg"]