[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,43,73,97,122,206,239,295,326,376,404,428,448,478,501,537,568,596,621,643,659,685,705,731,779],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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",false,"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.","ALL","18 Years","75 Years",{"count":21,"type":22},34,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29],"Gastroesophageal Junction Adenocarcinoma","Gastric Adenocarcinoma","RECRUITING","2026-08-17",{"date":33,"type":34},"2026-08-20","ACTUAL",{"date":36,"type":34},"2026-05-10",{"date":38,"type":22},"2028-11",{"name":40,"class":41},"Yongxu Jia","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"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":52,"type":22},148,[25,54],"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.",[29,28,57],"Peritoneal Carcinomatosis",[59,60,49,61,62],"EA2234","Intraperitoneal Paclitaxel","STOPGAP I","Gastric Carcinomatosis",{"date":64,"type":34},"2026-08-19",{"date":66,"type":34},"2025-08-19",{"date":68,"type":22},"2030-05-30",{"name":70,"class":71},"ECOG-ACRIN Cancer Research Group","NETWORK",78,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100596280","phase-3-a-study-to-investigate-tislelizumab-administered-as-subcutaneous-injection-versus-intravenous-infusion-plus-chemotherapy-in-patients-with-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100596280","NCT07043400","A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed, locally advanced unresectable or metastatic gastric\u002F gastroesophageal junction (GEJ) adenocarcinoma.\n* No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n* At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.\n* Must be able to provide tumor tissues for biomarker assessment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.\n* Adequate organ function.\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.\n\nExclusion Criteria:\n\n* Squamous cell or undifferentiated or other histological type gastric cancer (GC)\n* Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.\n* Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).\n* Active autoimmune diseases or history of autoimmune diseases that may relapse.\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to randomization\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":81,"type":22},351,[54],"This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.",[85,28],"Metastatic Gastric Adenocarcinoma","2026-08-06",{"date":88,"type":34},"2026-08-07",{"date":90,"type":34},"2025-08-27",{"date":92,"type":22},"2028-04-22",{"name":94,"class":95},"BeOne Medicines","INDUSTRY",95,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100541015","phase-1-beamion-bcgc-1-a-study-to-find-a-suitable-dose-of-zongertinib-used-alone-and-in-combination-with-other-treatments-to-test-whether-it-helps-people-with-different-types-of-her2-cancer-that-has-spread-100541015","NCT06324357","Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread","Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)","Inclusion criteria:\n\n* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)\n* Cohorts A to K and Cohort O: Documented Human epidermal growth factor receptor 2 overexpressing and\u002For amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).\n* Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression\u002Famplification according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) gastric cancer guidelines and according to the result of local testing.\n* For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue\n* History of prior treatment lines in palliative setting:\n\n  * For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd).\n  * For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.\n* Presence of at least one measurable lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Previous treatment with:\n\n  * Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL).\n  * T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.\n  * trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL.\n  * Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL\n* Presence of uncontrolled and\u002For symptomatic brain metastases, or leptomeningeal disease\n* Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \\>470 msec.\n* Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.\n* Ejection fraction \\\u003C50% or the lower limit of normal of the institutional standard within 28 days prior to randomization\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.",{"count":105,"type":22},768,[107,25],"PHASE1","This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.\n\nIn this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.\n\nDuring the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT\u002FMRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.",[110,85,28,111,112],"Metastatic Breast Cancer","Esophageal Adenocarcinoma","Colorectal Cancer","2026-08-05",{"date":86,"type":34},{"date":116,"type":34},"2024-06-28",{"date":118,"type":22},"2029-01-08",{"name":120,"class":95},"Boehringer Ingelheim",105,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":17,"minAge":130,"maxAge":19,"enrollmentInfo":131,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years",{"count":132,"type":22},2000,"OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[136,137,138,139,140,141,142,143,28,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma","2026-08-04",{"date":113,"type":34},{"date":200,"type":34},"2022-08-18",{"date":202,"type":22},"2027-02-28",{"name":204,"class":41},"Alliance for Clinical Trials in Oncology",744,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":42},"100409709","phase-1-nbtxr3-chemotherapy-and-radiation-therapy-for-the-treatment-of-esophageal-cancer-100409709","NCT04615013","NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer","A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus","Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction\n* Adenocarcinoma of the esophagus stages II-III allowed\n* Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:\n\n  * Oxaliplatin and fluorouracil (5-FU) or capecitabine\n  * Docetaxel and\u002For 5-FU or paclitaxel\n  * Carboplatin and paclitaxel\n* Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician\n\n  * Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion\n* Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \\[RECIST\\] version \\[v\\] 1.1) at the same anatomical location should be achievable\n\n  * Local nodal disease around the esophagus allowed\n  * Nodal target lesions must be \\>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Hemoglobin \\>= 8.0 g\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN)\n* Calculated (Calc.) creatinine clearance \\> 30 mL\u002Fmin\n* Glomerular filtration ratio \\> 40 mL\u002Fmin per 1.73 m\\^2\n* Total bilirubin =\\\u003C 2.0 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN)\n* Negative urine or serum pregnancy test =\\\u003C 7 days of NBTXR3 injection in all female participants of child-bearing potential\n* Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Prior radiation or any therapy for the treatment of esophageal cancer\n* Prior surgical resection of esophageal tumor\n* Esophageal cancer with radiographic evidence of metastases at screening\n* At screening, past medical history of:\n\n  * Esophageal fistula\n  * Tracheoesophageal fistula\n  * Siewert type III tumors\n* Evidence of bulky disease and\u002For abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician\n\n  * Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed\n* Known uncontrolled (grade \\>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment\n* Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast\n* Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment\n* Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Female patients who are pregnant or breastfeeding\n* Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \\\u003C 1% per year when used consistently and correctly\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":214,"type":22},24,[107],"The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.",[218,219,220,221,222,28,223,224,225,226,227,228,229],"Cervical Esophagus Adenocarcinoma","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Pathologic Stage II Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage III Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8","Thoracic Esophagus Adenocarcinoma","2026-07-22",{"date":232,"type":34},"2026-07-24",{"date":234,"type":34},"2020-11-23",{"date":236,"type":22},"2027-10-31",{"name":238,"class":41},"M.D. Anderson Cancer Center",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":262,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":294},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":247,"type":22},310,[107],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[251,252,253,254,255,256,257,258,28,259,111,260,261],"Advanced\u002FMetastatic Solid Tumors","Bladder Cancer","Urothelial Carcinoma","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Esophageal Squamous Cell Carcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer",[263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","NSCLC","head and neck cancer","HNSCC","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6","2026-07-21",{"date":230,"type":34},{"date":289,"type":34},"2025-08-20",{"date":291,"type":22},"2029-07-08",{"name":293,"class":95},"Pfizer",30,{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":312,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":303,"type":22},914,[107],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[307,308,309,310,28,311],"Colorectal Neoplasms","Carcinoma, Non-Small-Cell Lung","Stomach Neoplasms","Pancreatic Ductal Adenocarcinoma","Small Cell Lung Carcinoma",[313,270,279,314,315,316,317],"CRC","GC","GEJ","SCLC","Seattle Genetics",{"date":230,"type":34},{"date":320,"type":34},"2023-11-20",{"date":322,"type":22},"2030-09-12",{"name":324,"class":95},"Seagen, a wholly owned subsidiary of Pfizer",48,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":353,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732","NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).",{"count":334,"type":22},134,[107,25],"This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[338,339,340,341,112,258,259,342,28,343,150,344,345,346,347,348,349,350,351,352,253],"Diffuse Astrocytoma, IDH-Mutant","Glioblastoma, IDH-wildtype","Brain Metastases, Adult","Cervical Cancer","Gastric Cancer","Head and Neck Squamous Cell Carcinoma","Merkel Cell Carcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer","Non-small Cell Lung Cancer","Renal Cell Carcinoma","Small Cell Lung Cancer","Squamous Cell Carcinoma",[354,355,356,357,358,359,360,361,362,363,364,365],"Astrocytoma","IDH-mutant","Glioblastoma","IDH-wildtype","Brain Metastases","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","2026-07-15",{"date":368,"type":34},"2026-07-16",{"date":370,"type":34},"2023-11-01",{"date":372,"type":22},"2027-08-31",{"name":374,"class":95},"Neonc Technologies, Inc.",7,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"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":384,"type":22},21,[25],"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.",[29,28],[389,390,391,392,342,28,393],"Retlirafusp Alfa","SHR-1701","CAPOX","Conversion Therapy","R0 Resection","NOT_YET_RECRUITING","2026-07-09",{"date":397,"type":34},"2026-07-17",{"date":399,"type":22},"2026-08-30",{"date":401,"type":22},"2032-08-30",{"name":403,"class":41},"Tang-Du Hospital",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":42},"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":412,"type":22},75,[25],"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.",[416,29,28,417,418],"ESCC","Esophageal Squamous Cell Carcinoma (ESCC)","GC\u002FGEJC","2026-07-08",{"date":421,"type":34},"2026-07-14",{"date":423,"type":22},"2026-08-31",{"date":425,"type":22},"2029-09-01",{"name":427,"class":41},"Sun Yat-sen University",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":42},"100632781","phase-3-a-study-comparing-bl-m05d1-with-the-investigators-choice-of-treatment-regimen-in-patients-with-claudin-cldn182-positive-advanced-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma-gcgejc-who-have-received-prior-first-line-treatment-100632781","NCT07518147","A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-Line Treatment","A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN) 18.2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-line Treatment","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;\n6. Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression;\n7. Ability to provide archived or fresh tumor tissue;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n12. Organ function levels must meet the requirements;\n13. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);\n14. Urine protein ≤2+ or \\\u003C1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test negative, and must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Prior anti-tumor treatment;\n2. Positive HER2 expression in tumor tissue;\n3. History of severe cardiovascular or cerebrovascular disease;\n4. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n6. Active autoimmune diseases and inflammatory diseases;\n7. Diagnosis of another malignancy within 3 years prior to the first dose;\n8. Hypertension poorly controlled by two antihypertensive medications;\n9. History of interstitial lung disease (ILD) requiring hormone therapy, etc.;\n10. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;\n11. Infection requiring clinical intervention within 2 weeks prior to randomization;\n12. Patients with poorly controlled blood glucose levels;\n13. Patients with active central nervous system metastases;\n14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;\n15. Imaging findings indicating tumor invasion or encasement of major blood vessels such as those in the chest, neck, or pharynx;\n16. History of allergic reactions to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Active infection requiring systemic treatment;\n20. Pregnant or breastfeeding women;\n21. Esophageal or gastric varices requiring intervention within the past three months, etc.;\n22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;\n23. Presence of other serious physical or laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study as judged by the investigator.",{"count":436,"type":22},438,[54],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC\u002FGEJC) who have received prior first-line treatment.",[342,28],"2026-07-07",{"date":419,"type":34},{"date":443,"type":34},"2026-05-15",{"date":445,"type":22},"2029-12",{"name":447,"class":95},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":477},"100646545","phase-2-chemoradiotherapy-and-shr-1701-in-patients-with-unresectable-gastric-cancer-100646545","NCT07689851","Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer","Safety and Efficacy of Radiotherapy Combined With Chemotherapy and SHR-1701, a PD-L1(Programmed Death-Ligand 1)\u002FTGF-β(Transforming Growth Factor-beta) Bispecific Antibody, in the Treatment of Unresectable Locally Advanced or Metastatic Gastric Cancer","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 75 years.\n2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Unresectable locally advanced or metastatic gastric cancer, with primary and metastatic lesions amenable to radiotherapy (excluding patients with brain metastases or extensive metastatic disease).\n4. HER2-negative disease.\n5. ECOG performance status of 0-1.\n6. At least one measurable lesion according to RECIST version 1.1.\n7. Adequate organ function, including:\n\n   * Hemoglobin ≥90 g\u002FL;\n   * White blood cell count ≥3.5 × 10⁹\u002FL;\n   * Absolute neutrophil count ≥1.5 × 10⁹\u002FL;\n   * Platelet count ≥100 × 10⁹\u002FL;\n   * Serum creatinine ≤1.0 × upper limit of normal (ULN);\n   * Blood urea nitrogen (BUN) ≤1.0 × ULN;\n   * Alanine aminotransferase (ALT) ≤1.5 × ULN;\n   * Aspartate aminotransferase (AST) ≤1.5 × ULN;\n   * Alkaline phosphatase (ALP) ≤1.5 × ULN;\n   * Total bilirubin (TBIL) ≤1.5 × ULN;\n   * Negative urine protein;\n   * Normal coagulation function.\n8. No contraindications to immunotherapy.\n9. No history of hypersensitivity to fluoropyrimidines or platinum-based agents.\n10. No prior surgery, chemotherapy, immunotherapy, or other antitumor therapy for gastric or gastroesophageal junction cancer since diagnosis.\n11. No previous radiotherapy to the intended irradiation sites.\n12. Ability to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Brain metastases or extensive metastatic disease.\n2. Prior treatment with PD-1, PD-L1, TGF-β, CTLA-4 inhibitors, or other investigational immunotherapies.\n3. Severe autoimmune diseases, including but not limited to active inflammatory bowel disease (Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or autoimmune vasculitis (e.g., Wegener's granulomatosis).\n4. Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis.\n5. Conditions associated with an increased risk of gastrointestinal perforation, including active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis, or other known risk factors.\n6. History of another malignancy, except adequately treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or carcinoma in situ of the cervix.\n7. Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable cardiac arrhythmia.\n8. Any physical examination findings, laboratory abnormalities, or uncontrolled medical conditions that, in the investigator's judgment, may interfere with study outcomes or increase the risk of treatment-related complications.\n9. Pregnant or breastfeeding women.\n10. Congenital or acquired immunodeficiency, including HIV infection, or a history of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n11. Active hepatitis B infection (HBV DNA ≥2,000 IU\u002FmL), active hepatitis C infection, or active tuberculosis.\n12. Receipt of any live or other prohibited vaccines within 4 weeks before study treatment. Seasonal inactivated influenza vaccines are permitted, whereas intranasal live attenuated influenza vaccines are not permitted.\n13. Concurrent treatment with other immunosuppressive agents, chemotherapy, investigational drugs, or long-term systemic corticosteroids.\n14. Psychiatric disorders, substance abuse, or social conditions that may compromise treatment compliance, as determined by the investigator.\n15. Known hypersensitivity or contraindication to any study treatment.",{"count":456,"type":22},60,[25],"Gastric Cancer is one of the leading causes of cancer-related death worldwide, and patients with unresectable locally advanced or metastatic disease have a poor prognosis. This study aims to evaluate the safety and efficacy of radiotherapy combined with CAPOX and SHR-1701, a PD-L1\u002FTGF-β bispecific antibody, in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. By improving local tumor control and enhancing systemic antitumor activity, this study seeks to increase the opportunity for curative-intent resection and improve survival outcomes in patients with advance gastric cancer.",[460,28],"Gastric Cancer (GC)",[462,391,390,463,464,465,466,467,468],"Radiotherapy","Immunotherapy","Chemotherapy","Unresectable gastric cancer","Metastatic gastric cancer","Locally advanced gastric cancer","PD-L1\u002FTGF-β bispecific antibody","2026-07-05",{"date":419,"type":34},{"date":472,"type":22},"2026-07-01",{"date":474,"type":22},"2029-07-30",{"name":476,"class":41},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",3,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":497,"leadSponsor":499,"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":325,"type":22},[25],"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.",[489,29,28],"Locally Advanced Gastric Cancer",[489,491,492,493],"HIPEC","Hyperthermic Intraperitoneal Chemotherapy","Peritoneal Recurrence","2026-07-02",{"date":440,"type":34},{"date":472,"type":22},{"date":498,"type":22},"2028-05-09",{"name":500,"class":41},"Shanghai Changzheng Hospital",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":521,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":536},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":509,"type":22},1006,[107],"This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[513,514,515,259,111,28,516,517,518,519,520,309],"Carcinoma, Non-Small Cell Lung","Squamous Cell Carcinoma of Head and Neck","HER2 Negative Breast Neoplasms","Ovarian Neoplasms","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms",[270,272,522,416,523,315,524,525,526,527,528,258,252,341,342,317],"cSCC","EAC","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer",{"date":530,"type":34},"2026-07-06",{"date":532,"type":34},"2020-06-08",{"date":534,"type":22},"2029-03-22",{"name":324,"class":95},158,{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100626103","phase-3-sonesitatug-vedotin-in-combination-with-capecitabine-with-or-without-rilvegostomig-in-participants-with-advanced-or-metastatic-gastric-gastroesophageal-junction-or-esophageal-adenocarcinoma-expressing-claudin182-100626103","NCT07431281","Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2","A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced\u002FMetastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)","Inclusion Criteria:\n\n* Capable of giving signed informed consent\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 informed consent.\n* Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma\n* Positive CLDN18.2 expression, as determined prospectively by central IHC testing\n* Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:\n\n  1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.\n  2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible\n* ECOG performance status of 0 or 1 with no deterioration to \\> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.\n* Minimum life expectancy of ≥ 12 weeks.\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.\n* Adequate organ and bone marrow function as specified in the protocol\n* Body weight ≥ 35 kg.\n* Sex and contraceptive requirements\n\nExclusion Criteria:\n\n* Known HER2-positive status\n* Significant or unstable gastric bleeding and\u002For untreated gastric ulcers.\n* Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.\n* CNS pathology\n* Clinically significant pleural effusions or ascites and\u002For pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter\u002Fdrain.\n* Require parenteral nutrition support due to gastric or gastrointestinal obstruction.\n* Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.\n* Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.\n* Cardiac abnormalities as outlined in the protocol\n* Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.\n* Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and\u002For chronic or active hepatitis B with HBV DNA ≥ 100 IU\u002FmL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled\n* Known partial or total DPD enzyme deficiency",{"count":545,"type":22},2130,[54],"The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.",[342,28,258],[550,551,552,553,554,555,556,557,558],"Advanced Gastroesophageal Junction (GEJ) Adenocarcinoma,","Advanced Gastric Adenocarcinoma,","Advanced Esophageal Adenocarcinoma,","Metastatic Gastric Adenocarcinoma,","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,","Metastatic Esophageal Adenocarcinoma,","Claudin 18.2,","PD-L1,","Human epidermal growth factor receptor 2 (HER2) Negative","2026-06-30",{"date":472,"type":34},{"date":562,"type":34},"2026-02-03",{"date":564,"type":22},"2031-10-27",{"name":566,"class":95},"AstraZeneca",286,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":42},"100646999","phase-2-zanidatamab-combined-with-chemotherapy-as-neoadjuvantconversion-therapy-for-her2-positive-ihc-3-or-ihc-2-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-a-phase-ii-open-label-study-100646999","NCT07685704","Zanidatamab Combined With Chemotherapy as Neoadjuvant\u002FConversion Therapy for HER2-Positive (IHC 3+ or IHC 2+) Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Phase II Open-Label Study","A Phase II Open-Label Study Evaluating the Efficacy and Safety of Zanidatamab Combined With Chemotherapy as Neoadjuvant\u002FConversion Therapy in Patients With HER2-Positive (IHC 3+ or IHC 2+) Locally Advanced or Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent (ICF).\n2. Histologically and radiologically (CT\u002FMRI) confirmed gastric or gastroesophageal junction adenocarcinoma.\n\n   * Neoadjuvant cohort: Clinical stage III (cT3-4aN+M0) or locally advanced unresectable (cT4bNany M0) assessed by MDT as not amenable to R0 resection, or technically resectable but with high-risk factors (e.g., bulky nodal fusion, invasion of critical structures).\n   * Conversion cohort: Not amenable to direct surgery (e.g., invasion of adjacent organs or vessels) or with distant metastases, including liver metastases (C-GCLM type I and II), confirmed retroperitoneal lymph node metastases, or other single-organ metastases.\n3. HER2-positive by IHC (3+; or 2+ with FISH testing). No time window restriction on FISH.\n4. Age 18-75 years, male or female.\n5. ECOG performance status 0-1; no contraindication to surgery.\n6. Adequate organ function for successful abdominal surgery.\n7. Life expectancy \\>= 3 months.\n8. Laboratory parameters within 7 days before enrollment:\n\n   1. WBC \\> 4.0 x 10\\^9\u002FL and \\\u003C 15 x 10\\^9\u002FL; ANC \\> 1.5 x 10\\^9\u002FL; Hb \\>= 90 g\u002FL; PLT \\>= 100 x 10\\^9\u002FL.\n   2. Total bilirubin \\\u003C= 1.5 x ULN; AST and ALT \\\u003C= 2.5 x ULN.\n   3. Creatinine \\\u003C= 1.5 x ULN, or CrCl \\> 60 mL\u002Fmin (Cockcroft-Gault).\n   4. No anticoagulation: INR and aPTT \\\u003C= 1.5 x ULN. On stable anticoagulation: maintain stable dose.\n9. Good compliance; able to complete protocol-specified examinations and specimen collection.\n10. Female patients of childbearing potential must agree to contraception from ICF signing through at least 5 months after last dose and refrain from breastfeeding. Male patients must agree to contraception from first dose through at least 7 months after last dose.\n\nExclusion Criteria:\n\n1. Synchronous or metachronous malignancies of other organs, or recurrent disease.\n2. Prior systemic therapy for gastric cancer (neoadjuvant cohort).\n3. History of malignancy within 5 years before screening, except those with \\> 90% 5-year overall survival.\n4. Significant cardiopulmonary dysfunction.\n5. Major surgery within 4 weeks before study treatment initiation, or anticipated major surgery during study period (excluding diagnostic procedures).\n6. Severe infection within 4 weeks before study treatment initiation.\n7. Prior chemotherapy or molecular targeted therapy (neoadjuvant cohort).\n8. Known hypersensitivity to study drugs or excipients, or history of severe allergic reactions to monoclonal antibodies.\n9. Factors affecting oral medication intake (e.g., dysphagia \\>= grade 2, chronic diarrhea).\n10. Significant uncontrolled comorbidities that may affect protocol compliance or interpretation of outcomes.\n11. Pregnancy or breastfeeding, or planning pregnancy during the study.\n12. Diagnosis of immunodeficiency or receiving systemic corticosteroid (\\> 10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 2 weeks before first dose.\n13. Active hepatitis B (HBV DNA \\>= 1 x 10\\^3 copies\u002FmL or \\>= 200 IU\u002FmL), positive anti-HCV, or positive HIV.\n14. Participation in another anti-tumor clinical trial within 28 days before first dose.\n15. Any condition that in the investigator's judgment may lead to premature study termination (e.g., serious illness including psychiatric disorders requiring concomitant treatment, severe laboratory abnormalities, family\u002Fsocial factors affecting subject safety or data collection).\n16. Patient or family refusal to sign informed consent.",{"count":576,"type":22},46,[25],"This is a phase II open-label study to evaluate the efficacy and safety of zanidatamab combined with chemotherapy as neoadjuvant\u002Fconversion therapy in patients with HER2-positive (IHC 3+ or IHC 2+) locally advanced or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma. The study consists of two cohorts: a neoadjuvant cohort (Simon's two-stage design, n=46) for treatment-naive stage III locally advanced disease, and an exploratory conversion cohort for oligometastatic disease. Patients receive zanidatamab (30 mg\u002Fkg Q3W) plus oxaliplatin-based chemotherapy, with or without PD-1 inhibitor (tislelizumab or sintilimab). The primary endpoint is pathological complete response (pCR).",[342,28,580],"HER2-positive Gastric Cancer",[582,583,584,585,586,277,587],"zanidatamab","HER2","neoadjuvant therapy","conversion therapy","gastric cancer","bispecific antibody","2026-06-29",{"date":530,"type":34},{"date":591,"type":22},"2026-07",{"date":593,"type":22},"2028-12",{"name":595,"class":41},"Zhifeng Zhao, PhD",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":618,"locationsCount":620},"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":604,"type":22},146,[25],"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.",[29,342,28],[609,28,610,611],"Gastric Cancer, Adenocarcinoma","TRK-950","CAPRIN-1","2026-06-18",{"date":614,"type":34},"2026-06-23",{"date":616,"type":34},"2023-10-04",{"date":559,"type":22},{"name":619,"class":95},"Toray Industries, Inc",27,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":630,"studyType":133,"phases":4,"briefSummary":631,"conditions":632,"keywords":4,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100644416","emotional-distress-and-pathologic-response-in-locally-advanced-gastricgej-adenocarcinoma-100644416","NCT07662070","Emotional Distress and Pathologic Response in Locally Advanced Gastric\u002FGEJ Adenocarcinoma","A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Willing to participate in this study.\n2. Age \\>18 years; both sexes are eligible.\n3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n4. Resectable locally advanced disease as assessed by imaging and\u002For multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.\n5. Planned to receive neoadjuvant therapy followed by curative-intent surgery.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. No prior systemic antitumor treatment for the current tumor at baseline.\n8. Able to understand and complete questionnaire assessments.\n9. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.\n4. Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.\n5. Any other condition judged by the investigator to make the participant unsuitable for enrollment.",{"count":629,"type":22},120,"3 Years","This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.",[29,28,633,634],"Emotional Distress","Pathologic Response","2026-06-17",{"date":614,"type":34},{"date":638,"type":22},"2026-06-26",{"date":640,"type":22},"2028-12-31",{"name":642,"class":41},"West China Second University Hospital",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":650,"targetDuration":630,"studyType":133,"phases":4,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":657,"leadSponsor":658,"locationsCount":4},"100644388","objective-sleep-characteristics-and-neoadjuvant-immunotherapy-response-in-gastricgej-cancer-100644388","NCT07662005","Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric\u002FGEJ Cancer","Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Prospective Observational Study","Inclusion Criteria:\n\n1. Age greater than 18 years, regardless of sex.\n2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.\n4. Scheduled to receive neoadjuvant therapy followed by radical surgery.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n6. No prior systemic anticancer therapy for the current tumor at study baseline.\n7. Willing to participate in the study and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.\n4. Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:\n\n   1. Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;\n   2. Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;\n   3. Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;\n   4. Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.\n5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.",{"count":629,"type":22},"This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.",[29,28,653,654],"Sleep","Pathological Response",{"date":614,"type":34},{"date":638,"type":22},{"date":640,"type":22},{"name":642,"class":41},{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":665,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":23,"phases":669,"briefSummary":670,"conditions":671,"keywords":673,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":42},"100641848","phase-2-taic-folfox-for-locally-advanced-ggeja-100641848","NCT07655024","TAIC FOLFOX for Locally Advanced G\u002FGEJA","FOLFOX-Based Transarterial Infusion Chemotherapy for Locally Advanced Gastric Cancer and Gastroesophageal Junction Adenocarcinoma: Protocol of an Open-Label, Multicentre, Single-arm, Phase Ⅱ Trial","TFLAG","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Pathologically diagnosed with G\u002FGEJA\n* Confirmed by the surgeon as initially unresectable advanced G\u002FGEJC\n* Contraindicated to surgery due to frailty or comorbidities\n* Expected survival period ≥ 3 months\n\nExclusion Criteria:\n\n* Primary malignant tumors\n* Gastrointestinal obstruction caused by lesions in the distal stomach, duodenum, pancreas or other organs\n* Acute infection, severe liver or kidney dysfunction or coagulation disorder\n* Allergic to the drugs or with mental disorders",{"count":668,"type":22},31,[25],"Gastric cancer is the fifth most common malignancy worldwide in terms of both incidence and mortality. The majority of cases are diagnosed at advanced stage-often presenting with severe complications such as malignant stricture, obstruction, bleeding, and cancer-related malnutrition-which impinge on quality of life and survival outcomes. For patients with unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (G\u002FGEJA), first-line systemic therapy remains predominantly platinum- and fluoropyrimidine-based combination chemotherapy, and targeted agents or immunotherapy can be added based on the expression of biomarkers. Under this standard approach, the median overall survival (mOS) for localized unresectable G\u002FGEJA is approximately 14-20 months. For metastatic G\u002FGEJA, the prognosis remains poor with an mOS of less than 1 year, despite the proven efficacy of chemotherapeutic agents. Moreover, up to 25% of cancer survivors report a significant decline in quality of life due to gastrointestinal symptoms during, soon after, or many years after treatment.\n\nInterventional oncology approaches-including trans-arterial infusion chemotherapy (TAIC), embolization (TAE), and chemoembolization (TACE)-represent promising locoregional therapeutic strategies. TAIC allows for the direct delivery of cytotoxic agents into the tumor-feeding arteries, thereby maximizing intra-tumoral drug concentration. As one of the most well-recognized applications, hepatic arterial infusion chemotherapy (HAIC) has been demonstrated in liver cancer by elevating local drug exposure, markedly enhancing antitumor efficacy while minimizing systemic adverse effects. Moreover, chemotherapeutic agents may exert secondary systemic activity against clinically or subclinically disseminated metastases upon systemic circulation, contributing to a sustained \"secondary chemotherapy\" effect. Owing to its favorable safety profile and preserved antitumor activity, TAIC is particularly suited for frail or elderly patients who are ineligible for surgery or conventional systemic chemotherapy.\n\nGiven the persistent limitations of current therapeutic paradigms, the feasibility and safety of trans-arterial therapy in the treatment of anti-tumor, hemostasis and obstruction relief for locally advanced G\u002FGEJC remains urgent. The present study aimed to assess the efficacy and safety of TAIC for locally advanced G\u002FGEJA.",[672,28],"Gastric Cancer (Diagnosis)",[674,675,676],"Unresectable Gastric cancer","Esophagogastric junction adenocarcinoma","Transarterial infusion chemotherapy","2026-06-15",{"date":635,"type":34},{"date":680,"type":34},"2025-11-01",{"date":682,"type":22},"2028-12-01",{"name":684,"class":41},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":23,"phases":694,"briefSummary":695,"conditions":696,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":697,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":703,"locationsCount":704},"100574868","phase-3-a-phase--study-of-rilvegostomig-in-combination-with-fluoropyrimidine-and-trastuzumab-deruxtecan-as-the-first-line-treatment-for-her2-positive-gastric-cancer-100574868","NCT06764875","A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer","A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)","Inclusion Criteria:\n\n1. HER2 positive for gastric cancer on a tumor biopsy.\n2. PD-L1 combined positive score (CPS) ≥ 1.\n3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.\n4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.\n5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. Have measurable target disease assessed by the Investigator based on RECIST v1.1.\n7. Have adequate organ and bone marrow function.\n8. LVEF ≥ 50% within 28 days before randomization.\n9. Adequate treatment washout period before randomization.\n\nExclusion Criteria:\n\n1. Lack of physiological integrity of the upper gastrointestinal tract.\n2. Known dihydropyrimidine dehydrogenase enzyme deficiency.\n3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.\n4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.\n5. Persistent toxicities caused by previous anti-cancer therapy.\n6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n7. Uncontrolled infection including tuberculosis and active hepatitis A infection.\n8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.\n9. Recent receipt of live, attenuated vaccine.\n10. Chronic\u002Factive HBV or HCV infection unless controlled.\n11. Clinically significant cardiac or psychological conditions.\n12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n13. History of (non-infectious) ILD\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n14. Lung-specific intercurrent clinically significant illnesses.\n15. Any active non-infectious skin disease requiring systemic treatment.\n16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).\n17. History of any of the following: drug-induced severe cutaneous adverse reaction.\n18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.\n19. Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.\n20. Current or prior use of immunosuppressive medication within 14 days before study intervention.",{"count":693,"type":22},840,[54],"This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.",[580,28],{"date":698,"type":34},"2026-06-16",{"date":700,"type":34},"2025-03-01",{"date":702,"type":22},"2030-12-09",{"name":566,"class":95},293,{"id":706,"slug":707,"hasResults":12,"nctId":708,"briefTitle":709,"officialTitle":710,"acronym":4,"eligibilityCriteria":711,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":712,"targetDuration":4,"studyType":23,"phases":714,"briefSummary":715,"conditions":716,"keywords":717,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":724,"lastUpdatePostDateStruct":725,"startDateStruct":726,"completionDateStruct":727,"leadSponsor":729,"locationsCount":42},"100641256","phase-2-mannatide-combined-with-capox-and-tislelizumab-for-advanced-gastric-cancer-100641256","NCT07655661","Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.","A Multicenter, Single-Arm, Phase II Study of Mannatide Combined With CAPOX and Tislelizumab as First-Line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma.","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma.\n2. Unresectable recurrent or metastatic disease confirmed by imaging and surgical evaluation.\n3. Age 18 to 75 years.\n4. Expected survival greater than 3 months.\n5. No prior systemic therapy for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Previous neoadjuvant or adjuvant therapy is allowed if completed at least 6 months before enrollment without evidence of recurrence or progression.\n6. ECOG performance status 0-1.\n7. At least one measurable lesion according to RECIST version 1.1.\n8. Availability of tumor tissue for PD-L1 testing.\n9. Adequate hematologic, hepatic, renal, and coagulation function.\n10. Recovery of prior treatment-related toxicities to Grade 0-1 or baseline level.\n11. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n12. Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n1. HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n2. Squamous cell carcinoma, undifferentiated carcinoma, or mixed histology.\n3. Active or uncontrolled central nervous system metastases.\n4. Uncontrolled pleural effusion, ascites, or clinically significant pericardial effusion.\n5. Weight loss greater than 20% within 2 months before enrollment.\n6. Major surgery within 28 days before enrollment.\n7. Prior anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitor therapy.\n8. Active autoimmune disease requiring systemic treatment.\n9. Active hepatitis B, hepatitis C, or HIV infection.\n10. Interstitial lung disease or uncontrolled systemic disease.\n11. Significant cardiovascular disease within 6 months before enrollment.\n12. Known hypersensitivity to study drugs or their components.\n13. Participation in another interventional clinical trial within 4 weeks before enrollment.\n14. History of substance abuse or severe psychiatric disorder.\n15. History of rheumatic heart disease or known hypersensitivity to mannatide.\n16. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.",{"count":713,"type":22},52,[25],"This is a multicenter, open-label, single-arm phase II study evaluating the efficacy and safety of mannatide in combination with CAPOX chemotherapy and tislelizumab as first-line treatment for patients with recurrent or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n\nEligible patients will receive oxaliplatin, capecitabine, tislelizumab, and oral mannatide. Tumor response will be assessed according to RECIST version 1.1. Patients without disease progression after induction treatment may continue maintenance therapy with capecitabine, tislelizumab, and mannatide.\n\nThe primary objective is to evaluate objective response rate (ORR). Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory analyses will investigate immune microenvironment changes and potential predictive biomarkers using blood, tumor tissue, and stool samples.",[29,28],[718,719,391,342,720,721,722,723],"Mannatide","Tislelizumab","Gastroesophageal Junction Cancer","Metastatic Gastric Cancer","First-Line Treatment","Phase II Study","2026-06-13",{"date":612,"type":34},{"date":472,"type":22},{"date":728,"type":22},"2029-07-01",{"name":730,"class":41},"Ming Liu",{"id":732,"slug":733,"hasResults":12,"nctId":734,"briefTitle":735,"officialTitle":736,"acronym":4,"eligibilityCriteria":737,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":738,"targetDuration":4,"studyType":23,"phases":740,"briefSummary":741,"conditions":742,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":770,"lastUpdatePostDateStruct":771,"startDateStruct":773,"completionDateStruct":775,"leadSponsor":777,"locationsCount":42},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":739,"type":22},50,[25],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[743,744,745,746,747,748,749,750,751,752,28,753,754,755,149,756,757,758,759,760,761,762,350,763,764,765,766,767,768,253,769],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Unresectable Urothelial Carcinoma","2026-06-05",{"date":772,"type":34},"2026-06-09",{"date":774,"type":34},"2024-04-30",{"date":776,"type":22},"2026-12-31",{"name":778,"class":41},"Mayo Clinic",{"id":780,"slug":781,"hasResults":12,"nctId":782,"briefTitle":783,"officialTitle":784,"acronym":4,"eligibilityCriteria":785,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":786,"targetDuration":4,"studyType":23,"phases":787,"briefSummary":788,"conditions":789,"keywords":4,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":790,"lastUpdatePostDateStruct":791,"startDateStruct":792,"completionDateStruct":794,"leadSponsor":796,"locationsCount":42},"100597524","phase-2-neoadjuvant-intra-tumoral-rp2-and-flot-in-gastroesophageal-adenocarcinoma-100597524","NCT07059611","Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma","Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n* Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform the appropriate surgical procedure based on patient's primary tumor site.\n* Patients must have normal organ and bone marrow function, as defined below, less than or equal to 14 days prior to the initiation of study therapy:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmicroliter\n  * Platelets ≥100,000\u002Fmicroliter\n  * Total bilirubin ≤ the institutional upper limit of normal (ULN).\n  * AST and ALT ≤ 2.5 times the institutional ULN\n  * Serum creatinine ≤ 1.5 times the institutional ULN\n  * Hemoglobin ≥ 9 g\u002FdL\n\nExclusion Criteria\n\n* Has received prior chemotherapy, radiation therapy, or immunotherapy (anti-programmed cell death protein-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) for the current malignancy.\n* Per the investigator, has contraindications to receiving chemotherapy with FLOT.\n* Per the sub-investigator (gastroenterologist) responsible for intra-tumoral injections or the investigator, patient has contraindications to repeated upper endoscopy for intra-tumoral injections. These could include medical conditions that would, per the judgment of the sub-investigator or investigator, inappropriately increase the risk of upper endoscopy.\n* Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on warfarin with a target international normalized ratio (INR) ≥ 2.5 that cannot be temporarily reversed to INR ≤ 1.7.\n* Active significant herpetic infections or prior complications of Herpes simplex virus-1 (HSV-1) infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \\[IV\\]) antivirals with known antiherpetic activity (e.g., acyclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of study treatment.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Available COVID-19 vaccines do not contain live virus and are allowed.\n* Has a condition requiring systemic treatment with corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of first study treatment administration.\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10mg\u002Fday of prednisone equivalents are permitted.\n* Prior organ transplantation including allogeneic stem-cell transplantation.\n* Has a previous or concurrent malignancy. Exceptions include:\n\n  * Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\n  * Prior malignancy has been completely excised or removed and patient has been continuously disease free for \\> 5-years\n* Has a positive test result for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection with hepatitis B or hepatitis C. Testing will be performed as part of screening on the study.\n\n  * Patients with a known history of hepatitis B or hepatitis C that have been effectively treated (with negative HBsAg and HCV RNA) will be eligible for enrollment on this criterion.\n* Has a known history of human immunodeficiency virus (HIV) with detectable viral load. HIV testing will not be performed as part of screening for the study.\n\n  * Patients with known HIV infection with an undetectable viral load and who are on a stable highly active antiviral regimen per the investigator's assessment will eligible to enroll.\n* Has a psychiatric illness, substance use, or other social conditions that, in the judgment of the investigator, would limit compliance with study requirements.",{"count":21,"type":22},[25],"The research study is being conducted to study whether performing injections of a new treatment, called RP2, directly into stomach and esophagus tumors along with standard chemotherapy (called FLOT) is safe and whether it does a better job of killing cancer before surgery compared to chemotherapy alone.",[29,111,28],"2026-06-03",{"date":770,"type":34},{"date":793,"type":22},"2026-09-01",{"date":795,"type":22},"2029-11-01",{"name":797,"class":41},"Abramson Cancer Center at Penn Medicine"]