[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer-gc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer-gc":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,45,80,110,146,169,201,230,284,312,343,372,406,442,464,489,512,538,565,593,614,643,665,685,712],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100652142","phase-2-concurrent-immunotherapy-and-systemic-therapy-with-stereotactic-body-radiation-therapy-sbrt-for-stage-iv-cancers-coinsss-iv-100652142",false,"NCT07770100","Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)","Inclusion Criteria:\n\n* Histologically proven advanced or stage IV head \\& neck, non-small cell lung cancer, cervical, esophageal, gastric, and gastroesophageal cancer at least 6 metastases that are eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites with at least 1 other lesion meeting RECIST criteria of which this additional lesion not be treated with SBRT (biopsies performed for diagnosis are standard of care).\n* At least 6 metastases eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites\n* The 1 irradiated lesion must have a max point dose of 5Gy or less.\n* Eligible for Immunotherapy for an FDA-approved indication as defined in section 6.1. NOTE: No limit is placed on prior systemic treatment unless it affects the eligibility for administration of immune checkpoint inhibitor therapy.\n* If prior treatment with chemotherapy or radiotherapy or surgery has occurred: Prior chemotherapy or radiation must have concluded \\> 21 days prior to the start of study treatment. Exception: study treatment can start within 2-3 days following GKS \\[gamma knife surgery\\] or whole brain radiation therapy \\[ WBRT\\], as long as patient is not experiencing ongoing\u002Fresidual AE's related to GKS or WBRT at discretion of treating physician.\n* First Line immunotherapy-based treatments only. The patient may have received prior cycles of immunotherapy, but has to be on the first line of immunotherapy-based treatments.\n* If non-small cell lung cancer patient with pembrolizumab, PD-L1 testing CPS score \\> or = to 50% will have to be shown\n* If cervical cancer patient on secondary line therapy with pembrolizumab, CPS score of \\> or = to 1 will have to be done. Please note, second line therapy with pembrolizumab is only allowed if the patient's first line of therapy did NOT include immunotherapy.\n* If non-small cell lung cancer on first line ipilimumab in combination with nivolumab, PD-L1 of 1% and negative epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.\n* If pembrolizumab is given for a gastric cancer, a PD-L1 expression (CPS =1) will need to be shown\n* If pembrolizumab is given as a single agent treatment after progression of one prior systemic therapy agent for esophageal or gastroesophageal squamous cell carcinoma histology, a PD-L1 (CPS=1) expression will have to be shown.\n* ECOG Performance Status 0 - 1 (see Appendix A).\n* Life expectancy \\> or equal to 6 months.\n* Adequate organ and bone marrow function prior to study treatment as defined by: Thresholds for lab values prior to initiation of study treatment.\n* ANC \\> or equal to 1,000\u002Fmm3\n* Platelets \\> or equal to 100,000\u002Fmm3\n* Total bilirubin \\\u003C or equal to or equal to 1.5 x ULN\n* AST and ALT - With hepatic metastasis, \\\u003C or equal to or equal to 5 x ULN. If no hepatic metastasis, \\\u003C or equal to 2.5 times x ULN\n* Creatinine Or Creatinine Clearance \\\u003C or equal to 1.5 x ULNand\u002For CrCl \\> or equal to 30ml\u002Fmin (per 24-hour urine collection) or calculated according to the Cockcroft-Gault formula (Appendix B)\n* No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for the past 3 years.\n* Non-pregnant and non-nursing women -Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.\n* Women of childbearing potential and men must agree to use adequate contraception methods prescribed their the patients primary care physician, urologist, or obstetrician\u002Fgynecologist prior to study entry and for the duration of study participation.\n* Subjects should use adequate birth control for at least 3 months after the last administration of immune checkpoint inhibitors.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Presence of \\\u003C or equal to 5 sites amenable to SBRT\n* Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor\n* No more than 7 metastatic sites to an organ, defined as liver, left lung, right lung, single anatomically bone site (e.g. femur, humerus, single vertebral body).\n\nNOTE: Multiple different vertebral bodies are allowed.\n\n* Peritoneal involvement, at the discretion of the study PI. NOTE: Peritoneal metastasis does not exclude GI nor cervical cancer, except in cases where there is a separate focus of spread to the peritoneum.\n* Presence of liver cirrhosis of any grade prohibits SBRT to the liver. NOTE: Pt can enroll to trial if receiving SBRT to other non-liver metastatic sites.\n* A plan that cannot meet organ at risk tolerance (as defined in section 6.7.2.1) Auto-immune diagnosis Medications prohibited while receiving concurrent SBRT: gemcitabine, Adriamycin, VEGF or BRAF inhibitors.\n\nNOTE: However, if the patient is on the prohibited agent(s), the patient is still eligible for the trial so long as the prohibited agent can safely be held for at least 1 month before starting SBRT, during SBRT, and 1 month after completion of SBRT.\n\n-Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury (injury requiring immediate surgical intervention or involving loss of consciousness) within 14 days prior to registration or those patients who receive a nonCNS minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 3 days prior to registration.\n\nNOTE: There is no waiting period for central line placement. There is a 7-day window for recovery prior to registration for patients who underwent stereotactic biopsy of the brain.\n\n* Active clinically serious infection \\> CTCAE Grade 2.\n* Serious non-healing wound, ulcer or bone fracture.\n* Uncontrolled inter-current illness. This includes, but is not limited to: ongoing or active infection; symptomatic congestive heart failure (NYHA class III or IV); unstable angina pectoris or new onset angina that began within the last 3 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; thrombotic\u002F embolic events such as cerebrovascular accident, including transient ischemic attacks within the past 6 months;\n* Uncontrolled hypertension defined as systolic blood pressure \\>150 mmHg or diastolic pressure \\> 90 mmHg, despite optimal medical management; Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C; Known Grade 3 or 4 neurotoxicity.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI.\n\nNote: Patients, if randomized, should not receive live vaccine while receiving ICI and up to 30 days after the last dose of ICI.\n\n-Inclusion of Women and Minorities - Consistent with NIH policy, both men and women of all races and ethnic groups are eligible for this trial.","ALL","18 Years","99 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.",[27,28,29,30,31],"Head and Neck Cancer","Non-Small Cell Lung Cancer","Cervical Cancer","Esophageal Cancer","Gastric Cancer (GC)","NOT_YET_RECRUITING","2026-08-18",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":21},"2026-10-01",{"date":40,"type":21},"2040-02-28",{"name":42,"class":43},"Mark Bernard","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100652514","phase-4-ferric-carboxymaltose-versus-iron-sucrose-for-iron-deficiency-anemia-after-radical-gastrectomy-for-gastric-cancer-100652514","NCT07772453","Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer","Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer: A Multicenter Open-Label Randomized Controlled Trial","IRIS","Inclusion Criteria:\n\n* Age 18 to 75 years, sex male or female, and body weight ≥ 50 kg.\n* Histopathologically confirmed gastric cancer (TNM stage I-III according to the AJCC 8th edition) and have undergone curative (R0) resection.\n* Postoperative anemia defined as a hemoglobin (Hb) level \\\u003C 100 g\u002FL within 24 hours after surgery (i.e., on postoperative day 1), meeting the diagnostic criteria for postoperative anemia in gastric cancer patients.\n* Evidence of iron deficiency, as indicated by:\n* serum ferritin \\\u003C 30 μg\u002FL, or\n* serum ferritin \\\u003C 100 μg\u002FL and transferrin saturation (TSAT) \\\u003C 20%, confirming iron-deficiency anemia.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Adequate hepatic, renal, and coagulation function, defined as:\n* ALT and AST ≤ 2.5 × upper limit of normal (ULN),\n* serum creatinine ≤ 1.5 × ULN,\n* prothrombin time international normalized ratio (INR) ≤ 1.5.\n* Estimated life expectancy ≥ 3 months.\n* Voluntary written informed consent and ability to comply with the trial treatment and follow-up procedures.\n\nExclusion Criteria:\n\nNon-iron-deficiency anemia (e.g., hemolytic anemia, thalassemia, megaloblastic anemia, aplastic anemia, tumor-related non-iron-deficiency anemia, etc.) or disorders of hemoglobin synthesis.\n\n* Known hypersensitivity to ferric carboxymaltose, iron sucrose injection, or any of their excipients.\n* Evidence of iron overload (serum ferritin \\> 1000 μg\u002FL) or a history of hemochromatosis.\n* Severe hepatic or renal impairment, defined as:\n* ALT\u002FAST \\> 2.5 × upper limit of normal (ULN),\n* serum creatinine \\> 1.5 × ULN,\n* or coagulopathy (INR \\> 1.5);\n* or active bleeding (e.g., major postoperative anastomotic hemorrhage, intra-abdominal bleeding, etc.).\n* Receipt of oral iron, intravenous iron, or erythropoiesis-stimulating agents (ESAs) \u002F erythropoietin (EPO) within the past 3 months prior to screening.\n* Concurrent other malignancies, severe cardiovascular disease (e.g., heart failure, history of myocardial infarction, severe arrhythmias), uncontrolled infectious disease (e.g., sepsis), or immunodeficiency disorders.\n* Pregnant or breastfeeding women, or women who plan to become pregnant during the trial period.\n* Inability to comply with the treatment and follow-up procedures (e.g., due to cognitive impairment, psychiatric disorders), or any other condition that, in the investigator's judgment, would render the participant unsuitable for inclusion in the study.","75 Years",{"count":55,"type":21},160,[57],"PHASE4","This is a multicenter, open-label, randomized controlled trial. A total of 160 patients with iron-deficiency anemia after radical gastrectomy for gastric cancer will be enrolled and randomly assigned in a 1:1 ratio. Subjects in the experimental group will receive a single-dose intravenous ferric carboxymaltose on postoperative day 1, while the control group will receive multiple intravenous infusions of iron sucrose to achieve an identical total iron dose. All participants will follow standardized postoperative nutritional support and transfusion criteria. The primary endpoint is the hemoglobin response rate at postoperative week 3. Secondary endpoints include changes in hemoglobin and iron-related biomarkers, transfusion requirements, postoperative complications, functional recovery, and the incidence of adverse events. This study aims to compare the efficacy and safety of the two intravenous iron preparations and provide evidence for optimal postoperative iron supplementation for gastric cancer surgical patients.",[31,60,61,62],"Iron Deficiency Anemia (IDA)","Post-Operative Anemia","Radical Gastrectomy",[64,65,66,67,68,69,70],"Ferric Carboxymaltose","Iron Sucrose","Intravenous Iron Supplementation","Gastrectomy","Postoperative Iron Deficiency","Gastric Cancer Surgery","Iron-deficiency Anemia","2026-08-16",{"date":73,"type":36},"2026-08-19",{"date":75,"type":21},"2026-08",{"date":77,"type":21},"2028-03",{"name":79,"class":43},"Zhaojian Niu,MD",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":107,"locationsCount":109},"100652145","the-prevalence-and-the-pathophysiological-role-of-non-helicobacter-pylori-helicobacter-spp-in-well-defined-gastric-diseases-and-pre--malignancies-100652145","NCT07770126","The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies","HELIS","Inclusion Criteria:\n\n* part of the study population\n\nExclusion Criteria:\n\n* Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples.\n* Pregnancy.\n* Underage patients (\\\u003C 18 years).",true,{"count":89,"type":21},150,"OBSERVATIONAL","The goal of this clinical trial is to discover the prevalence of NHPH bacteria (Non-Helicobacter pylori Helicobacter species) in patients with one of the following conditions:\n\n1. Functional dyspepsia following the Rome IV criteria\n2. Active chronic gastritis, non-H. pylori induced atrophic gastritis, intestinal metaplasia and non-H.pylori gastric dysplasia\n3. Gastric cancer, including siewert type 2 and 3 esophagastric junction cancers In addition, patients undergoing bariatric surgery are included as a control group. This study will be conducted using a prospective analysis in the three targeted study populations. Biopsy specimens routinely taken during the medical procedure or via the resected material in patients belonging to the target groups will be used.\n\nExclusion criteria:\n\n* Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples.\n* Pregnancy.\n* Underage patients (\\\u003C 18 years).",[93,94,95,31,96,97,98,99,100],"Functional Dyspepsia","Gastritis","Gastritis Chronic","Atrophic Gastritis","Intestinal Metaplasia of Gastric Mucosa","Dysplasia Stomach","Helicobacter Infection","NHPH Prevalence","RECRUITING","2026-08-12",{"date":33,"type":36},{"date":105,"type":36},"2025-02-24",{"date":77,"type":21},{"name":108,"class":43},"Universiteit Antwerpen",3,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":130,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":145},"100649839","phase-1-iks04-regimen-in-advanced-solid-tumors-that-express-ca242-100649839","NCT07738939","IKS04 Regimen in Advanced Solid Tumors That Express CA242","A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242","Key Inclusion Criteria:\n\n* Advanced or metastatic CRC, BTCs, GEA, and PDAC that is histologically or cytologically confirmed\n* Disease that has progressed despite prior treatment, for which additional effective therapy is not available, not tolerable, is contraindicated, or the participant refuses standard therapy.\n* Platelets ≥ 100,000 \u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL., no transfusions with RBCs are allowed within 2 weeks prior to first trial drug administration\n* ANC ≥ 1500\u002FmcL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present\n* Total bilirubin ≤ 1.5 x ULN, unless participant has Gilbert's Syndrome\n* Albumin \\> 2.5 g\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\nPart I\n\n* Fresh biopsy tissue or formalin-fixed paraffin-embedded (FFPE) tumor tissue block or slides available for retrospective assessment of CA242 positivity in a central laboratory.\n* Measurable and non-measurable disease\n\nPart II\n\n* Fresh biopsy tissue or FFPE tumor tissue block or slides for assessment of CA242 positivity in a central laboratory prior to administration of first dose of study drug.\n* Measurable disease only\n\nKey Exclusion Criteria:\n\n* Participants with a significant pulmonary disease or condition, including:\n\n  * Significant symptomatic chronic obstructive pulmonary disease (COPD), as assessed by the Investigator.\n  * History or any current evidence on imaging studies of interstitial lung disease (ILD), pulmonary fibrosis.\n  * History of pulmonary inflammatory disease, pneumonitis, acute respiratory distress syndrome (ARDS).\n  * History of pneumonia within 3 months prior to the first trial drug administration.\n* Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.\n* Participant may not have received more than 5 prior lines of systemic therapy.\n* Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration\n* Central nervous system metastatic disease unless treated prior to first dose of trial drug.\n* Active second malignancy or history of another malignancy within the last 2 years with specific exceptions as per protocol\n* Active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome requiring systemic steroids or other immunosuppressive medications, such as:\n\n  * Myocarditis, pneumonitis, glomerulonephritis.\n  * Autoimmune hepatitis, inflammatory bowel disease (IBD)\n  * Sjogren's syndrome\n  * Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)\n  * Myositis\n  * Myasthenia gravis\n  * Guillain-Barré Syndrome\n  * Multiple sclerosis\n  * Granulomatosis with polyangiitis (Wegner's granulomatosis)\n  * Vasculitis",{"count":118,"type":21},120,[120],"PHASE1","This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.",[123,124,31,125,126,127,128,129],"Colorectal Cancer","Gastro Esophageal Junctional Cancer","GEJ Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","Gall Bladder Cancer","Cholangiocarcinoma",[131,132,133,134],"CA242","advanced gastrointestinal tumors","IKS04","Isumab04","2026-07-27",{"date":137,"type":36},"2026-07-31",{"date":139,"type":21},"2026-11",{"date":141,"type":21},"2029-12",{"name":143,"class":144},"Iksuda Therapeutics Ltd.","INDUSTRY",4,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100649442","developing-and-testing-the-effectiveness-of-smart-healthcare-assisted-individualized-symptom-management-education-and-home-based-exercise-on-frailty-treatment-related-adverse-events-and-quality-of-life-in-advanced-gastric-cancer-patients-receiving-immunotherapy-100649442","NCT07732543","Developing and Testing the Effectiveness of Smart Healthcare Assisted Individualized Symptom Management Education and Home-based Exercise on Frailty, Treatment-related Adverse Events and Quality of Life in Advanced Gastric Cancer Patients Receiving Immunotherapy","Inclusion Criteria:\n\n1. age ≥18 years\n2. diagnosed as AGC (TNM: T2\\~T4, N\\>0, Any M, Stage: III\\~IV, or unresectable GC)\n3. scheduled to receive the first cycle of immunotherapy\n4. willingness to provide written informed consent after receiving a full explanation of the study\n\nExclusion Criteria:\n\n1. a diagnosis of another type of cancer within the past five years\n2. inability to communicate clearly\n3. a diagnosis of dementia\n4. acute pulmonary embolism\n5. acute myocardial infarction\n6. extremity bone fracture within the past three months\n7. bone metastasis",{"count":153,"type":21},110,[155],"NA","The goal of this randomized controlled intervention is to develop and evaluate the effectiveness of the nurse-led with AI chatbot Individualized Symptom Management Education and Home-based Exercise (AI-ISME\\&HE) based on The Theory of Symptom Self-Management (TSSM) on frailty, self-efficacy in cancer care, trAE, and quality of life in advanced gastric cancer patients receiving immunotherapy. The main questions it aims to answer are:\n\n* Can AI-ISME\\&HE reduces frailty in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE increases quality of life in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE increases self-efficacy in advanced gastric cancer patients receiving immunotherapy?\n* Can AI-ISME\\&HE reduces all-caused death in advanced gastric cancer patients receiving immunotherapy within two years? Researchers will compare usual routine care to see if AI-ISME\\&HE can reduce frailty, all-caused death and increase quality of life and self-efficacy.\n\nParticipants will not be blinded, but the outcome evaluator will be blinded. The participants will be asked to complete three tasks for 12 weeks:\n\n* Self-reporting treatment-related adverse events\n* Interacting with AI-ISME\\&HE for seeking information related to self-management educational materials, including symptom management with the most reported trAEs and prevention from frailty\n* ViviFrail-based exercise",[31,158],"Immunotherapy","2026-07-23",{"date":161,"type":36},"2026-07-29",{"date":163,"type":21},"2026-07-21",{"date":165,"type":21},"2030-07-31",{"name":167,"class":168},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100647932","teas-timing-for-gastrectomy-recovery-teas-time-trial-100647932","NCT07714980","TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)","Effect of Perioperative vs Postoperative-Only Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Recovery and Pain Control After Laparoscopic Radical Gastrectomy: A Multicenter， Three-Arm, Randomized, Sham-Controlled Trial","Inclusion Criteria:\n\n* Age 18 to 80 years, both sexes\n* Endoscopically and radiographically confirmed resectable stage I-III gastric cancer (AJCC 8th edition)\n* Scheduled to undergo laparoscopic radical gastrectomy\n* Willing to sign the informed consent form and able to comply with all study procedures\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status ≥ IV\n* Clinical stage IV gastric cancer\n* Severe hepatic, renal, cardiovascular, or cerebrovascular diseases, or uncontrolled psychiatric disorders that may affect compliance or safety assessment\n* Participation in another clinical trial or receipt of any form of acupoint stimulation (acupuncture, electroacupuncture, TEAS, etc.) within 1 month prior to enrollment\n* Continuous use of opioids for more than 3 months prior to enrollment, with a daily dose ≥ 30 mg oral morphine equivalent\n* Implanted cardiac pacemaker or other electronic stimulation device, or skin infection\u002Flesion at the stimulation site\n* Pregnancy or lactation\n* Emergency surgery due to bleeding, perforation, obstruction, etc.\n* Planned epidural anesthesia for the surgery","80 Years",{"count":178,"type":21},300,[155],"The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS) works to help people recover faster after laparoscopic surgery for stomach cancer. TEAS is a treatment that uses small electrical pulses through sticky pads on the skin. It does not use needles.\n\nThe main questions it aims to answer are:\n\nDoes TEAS help people pass gas (a sign that the digestive system is waking up) sooner after surgery?\n\nDoes TEAS help lower pain after surgery?\n\nDoes TEAS reduce the need for extra pain medication after surgery?\n\nResearchers will compare three groups to see if TEAS works better when given before, during, and after surgery compared with only after surgery.\n\nGroup 1 receives TEAS before, during, and after surgery.\n\nGroup 2 receives a sham (inactive) treatment before and during surgery, and real TEAS after surgery.\n\nGroup 3 receives sham treatment at all time points.\n\nAll participants will receive the same standard pain relief and recovery care after surgery.\n\nParticipants will:\n\nBe randomly assigned (like flipping a coin) to one of the three groups\n\nReceive TEAS or sham treatment for 30 minutes before surgery, during surgery, and for 30 minutes each day on the first 3 days after surgery\n\nRate their pain on a 0-10 scale at 6, 12, 24, 48, and 72 hours after surgery\n\nComplete quality-of-life questionnaires before surgery, on day 4 after surgery, and 30 days after surgery\n\nHave a follow-up visit or phone call 30 days after leaving the hospital\n\nThis study includes 300 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 13 hospitals in Shandong Province, China.",[31,182],"Stomach Neoplasms",[184,182,185,186,187,188,189,190,191],"Gastric Cancer","Transcutaneous Electrical Acupoint Stimulation","TEAS","Acupoint Stimulation","Randomized Controlled Trial","Postoperative Recovery","Pain Management","Gastrointestinal Function","2026-07-19",{"date":163,"type":36},{"date":195,"type":21},"2026-07",{"date":197,"type":21},"2028-08",{"name":199,"class":43},"The Affiliated Hospital of Qingdao University",13,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100645452","phase-2-68gabed003-pet-imaging-of-fibroblast-activation-protein-in-selected-oncology-indications-100645452","NCT07702292","[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications","Inclusion Criteria:\n\n1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.\n2. Participants must be ≥ 18 years and \\\u003C 80 years of age and competent to give informed consent.\n3. Eastern Cooperative Oncology Group performance status ≤ 2.\n4. Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET\u002FCT imaging visit (Visit 2) prior to \\[68Ga\\]BED003 administration.\n\n   Note: If combining screening (Visit 1) and the PET\u002FCT imaging visit (Visit 2) into a single visit, a serum pregnancy test must be used to exclude pregnancy.\n5. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET\u002FCT imaging visit (Day 1\u002FVisit 2) to the safety follow-up telephone call (Day 3\u002FVisit 3).\n6. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).\n\n   Note: Invasive breast cancer with mixed ductal\u002Flobular histology is permitted.\n7. Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before \\[68Ga\\]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.\n8. Either:\n\n   1. Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.\n   2. Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.\n   3. Suspected recurrence after definitive therapy.\n\nExclusion Criteria:\n\n1. Participants administered any radioisotope within 5 physical half-lives prior to \\[68Ga\\]BED003 administration.\n2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \\[68Ga\\]BED003 administration.\n3. Participants who have recently received any other contrast agent (\\\u003C 24 hours for IV agents and \\\u003C 5 days for oral agents) before the day of \\[68Ga\\]BED003 administration.\n4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.\n5. Known hypersensitivity to \\[68Ga\\]BED003 or any of its constituents.\n6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion, including, but not limited to, the following:\n\n   1. Any other primary cancers that could confound the interpretation of the study results.\n   2. Major surgery (such as laparoscopy\u002Flaparotomy\u002Fthoracotomy) over the 3 months preceding screening that could confound the interpretation of the study results.\n   3. Serious, non-healing wound, ulcer, or bone fracture.\n   4. Active hepatitis.\n   5. Significant cardiac disorders including recent (in last 3 months) myocardial infarction or clinically significant electrocardiogram (ECG) findings.\n7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgement, excluding disorders directly related to the index cancer (e.g. tumour-associated pancreatitis or biliary stasis for PDAC).\n8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.\n9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.\n10. Significant renal impairment, defined as an estimated glomerular filtration rate (as determined by the Modification of Diet in Renal Disease formula) below 45 mL\u002Fmin\u002F1.73m2 or a serum creatinine \\> 1.5 × the upper limit of normal.\n11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from from the PET\u002FCT imaging visit (Day 1\u002FVisit 2) to the safety follow-up telephone call (Day 3\u002FVisit 3).","79 Years",{"count":210,"type":21},65,[24],"This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of \\[68Ga\\]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).",[123,214,31,215,216],"Epithelial Ovarian Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Invasive Lobular Breast Carcinoma",[218,219],"Positron emission tomography","Fibroblast activation protein","2026-07-14",{"date":222,"type":36},"2026-07-15",{"date":224,"type":36},"2026-06-30",{"date":226,"type":21},"2028-02",{"name":228,"class":144},"Blue Earth Diagnostics",6,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":259,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100647234","phase-1-fapi-pet-imaging---an-exploratory-study-100647234","NCT07705074","FAPI PET Imaging - An Exploratory Study","FAPI PET Imaging - a Multicentric Exploratory Evaluation","FAPIPET","Inclusion Criteria:\n\n* Written informed consent obtained and documented by the participant's signature.\n* Age ≥18 years at the time of consent.\n* Clinically established or suspected diagnosis or recurrence of an oncologic or non-oncologic disease as defined in chapter 7.1 of study protocol.\n* Availability of standard-of-care imaging (e.g., clinically established PET tracer or anatomical imaging such as CT\u002FMRI) to allow comparative evaluation.\n\nExclusion Criteria:\n\n* Severe claustrophobia that would preclude PET imaging.\n* Inability to remain still for the duration of the PET\u002FMR examination.\n* Current pregnancy or breastfeeding; no pregnancy test is required for women who are postmenopausal for ≥12 months or have undergone surgical sterilization, bilateral oophorectomy, or hysterectomy.\n* Previous hypersensitivity reactions to radiotracer administration\n* Inability to understand the study information, for example due to language barriers.\n* Subjects incapable of judgment (e.g. individuals under legal or medical incapacity).\n* Participants scheduled for PET\u002FMR imaging: Presence of MRI-incompatible metallic implants, electronic devices (e.g. pacemakers, cochlear implants), or other ferromagnetic foreign bodies.",{"count":239,"type":21},770,[120,24],"This study is testing a new imaging tracer called \\[18F\\]FAPI-74 with PET scans. Researchers want to find out how well this tracer shows certain diseases in the body, including several types of cancer and some non-cancer conditions like fibrosis and sarcoidosis.\n\n\\[18F\\]FAPI-74 attaches to a protein found on cells that are active in tumors and areas of scarring or inflammation. This may help doctors see these areas more clearly than with imaging methods used today, especially in diseases where current scans do not work well.\n\nPeople who join this study will get one injection of the tracer into a vein, then have one PET\u002FCT or PET\u002FMR scan. This takes about 2 hours in total. Researchers will compare the results with imaging the participant already had as part of their regular care, such as other PET scans, CT, or MRI. No extra treatment is given, and no other visits are needed.\n\nThe study will take place at 5 hospitals in Switzerland and plans to include about 770 adults with a confirmed or suspected diagnosis of one of the conditions being studied. The main goal is to see how clearly the tracer shows up on the scan. Researchers will also look at whether this new scan changes how confident doctors feel about a diagnosis, or changes the patient's treatment plan.",[243,244,245,246,247,248,249,31,250,251,252,253,254,255,256,257,258],"Thyroid Pathology","Head and Neck Cancer (H&N)","Sinonasal Tract Tumor","Sarcoidosis","Thyroid Cancer","Breast Cancer","Hepatocellular Carcinoma (HCC)","Pancreatic Cancer, Adult","Urothelial Carcinoma (UC)","Multiple Myeloma or Plasmacytoma","Mesothelioma","Hepatic Fibrosis","Endometriosis (Diagnosis)","Lung Fibrosis","Neck Node Metastasis","Prostate Cancer (CRPC)",[260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275],"[18F]FAPI-74","Fibroblast Activation Protein","FAP-targeted imaging","PET\u002FCT","Radiotracer","Diagnostic imaging","Multicentric study","Radiopharmaceutical","FAPI","FAPI-74","nuclear medicine","University Hospital Zurich","swiss multicenter trial","Cancer-associated fibroblast imaging","oncologic imaging","non-oncologic imaging","2026-07-09",{"date":222,"type":36},{"date":75,"type":21},{"date":280,"type":21},"2029-09",{"name":282,"class":43},"Martin Huellner",5,{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":87,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":293,"conditions":294,"keywords":297,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":44},"100610220","a-noninvasive-and-screening-mirna-signature-for-gastrointestinal-cancer-100610220","NCT07224750","A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer","MiGIC","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of blood sample collection.\n2. Patients with a confirmed diagnosis of one of the following gastrointestinal cancers: Hepatocellular carcinoma (HCC), Cholangiocarcinoma (CCA), Pancreatic ductal adenocarcinoma (PDAC), Esophageal squamous cell carcinoma (ESCC), Gastric cancer (GC), Colorectal cancer (CRC), Non-cancer control participants, including healthy volunteers or patients with benign gastrointestinal conditions.\n3. Availability of retrospective blood samples collected according to institutional protocols.\n4. Willingness to allow use of de-identified clinical and demographic data for research purposes.\n\nExclusion Criteria:\n\n* other active malignancies; insufficient sample quality\u002Fvolume; recent chemotherapy\u002Fradiotherapy\u002Fsurgery; any condition preventing reliable participation.",{"count":292,"type":21},1000,"Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor.\n\nCirculating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.",[249,129,215,295,31,296],"Esophageal Squamous Cell Carcinoma (ESCC)","Colorectal Cancer Screening",[298,299,300,301,302],"Noninvasive screening","Circulating miRNA","Machine learning","Gastrointestinal cancer","Blood-based cancer detection","2026-07-06",{"date":305,"type":36},"2026-07-07",{"date":307,"type":36},"2024-06-21",{"date":309,"type":21},"2028-06-18",{"name":311,"class":43},"City of Hope Medical Center",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":109},"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":320,"type":21},60,[24],"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.",[31,324],"Gastroesophageal Junction Adenocarcinoma",[326,327,328,158,329,330,331,332,333],"Radiotherapy","CAPOX","SHR-1701","Chemotherapy","Unresectable gastric cancer","Metastatic gastric cancer","Locally advanced gastric cancer","PD-L1\u002FTGF-β bispecific antibody","2026-07-05",{"date":336,"type":36},"2026-07-08",{"date":338,"type":21},"2026-07-01",{"date":340,"type":21},"2029-07-30",{"name":342,"class":43},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100609678","phase-3-using-18f-fapi-pet-to-detect-metastatic-disease-in-patients-that-have-gastric-or-esophageal-cancer-100609678","NCT07217704","Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.","A Phase 3, Multicenter, Prospective Open-Label Study of the Diagnostic Performance of [¹⁸F]FAPI-74 PET\u002FCT for the Detection of Metastatic Disease in Adults With Gastric or Esophageal Cancer","FAPI-GO","Inclusion Criteria:\n\n* Male and female adults ≥ 18 years.\n* Participants with confirmed gastric, esophageal or gastroesophageal malignancy undergoing staging evaluation for treatment planning.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Provided signed, written informed consent prior to any study-related procedures.\n* Participants are required to have a ceCT scan of chest, abdomen and pelvis as per standard clinical practice and practice guidelines either 21 days or less prior to entry or planned within 21 days of \\[¹⁸F\\]FAPI-74 administration.\n* For women who are not postmenopausal (two years of amenorrhea) or surgically sterile (absence of ovaries and\u002For uterus): agreement to use medically accepted, highly effective methods of contraception (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, during the trial intervention period.\n\nExclusion Criteria:\n\n* Unequivocal evidence of metastases at the time of enrollment that would preclude surgery as a treatment option.\n* Known hypersensitivity to \\[¹⁸F\\]FAPI-74.\n* Administration of another investigational diagnostic or therapeutic product within 30 days prior to \\[¹⁸F\\]FAPI-74 administration.\n* Prior administration of a radiopharmaceutical within 10 half-lives of that product from the time of \\[¹⁸F\\]FAPI-74 administration.\n* Previous cancer (except basal cell carcinoma of the skin or in situ carcinoma of the cervix\u002Futerus (participants treated with curative intent and disease free for more than 5 years are permitted).\n* Hepatic function: T. bili \\>1.5X ULN or alk phos, ALT, or AST \\>5X ULN\n* Renal function: GFR \\\u003C 30 mL\u002Fmin\n* Pregnant or currently breast feeding (a negative pregnancy test is required in women of childbearing potential).\n* Inability to undergo the PET\u002FCT scanning procedure.\n* Inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n* Sarcoidosis\n* Treatment, including chemotherapy, radiation, immunotherapy or surgery for curative intent of Gastroesophageal cancers",{"count":352,"type":21},200,[354],"PHASE3","This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of \\[¹⁸F\\]FAPI-74 PET\u002FCT in the detection of metastatic disease in individuals with pathologically confirmed gastric, gastroesophageal junction or esophageal cancer. Following screening, using a standardized administration protocol and dose, participants will undergo \\[¹⁸F\\]FAPI-74 PET\u002FCT screening. SOC procedures and interventions will be captured during 3 months +\u002F-14 days post injection. The primary objective is to evaluate the sensitivity and specificity of such \\[¹⁸F\\]FAPI-74 PET\u002FCT using a composite SOT panel. The maximum expected duration of the trial is approximately 24 months from first patient screening to last patient SOC follow up. The participants will be followed-up for safety for 24 to 72 hours after the dose of \\[¹⁸F\\]FAPI-74 PET\u002FCT.",[30,31,357],"Gastroesophageal Junction",[359,261,360,268,361,362],"FAP","Fibroblast Activation Protein Inhibitor","gastroesophageal cancer","PET","2026-06-26",{"date":224,"type":36},{"date":366,"type":36},"2025-11-14",{"date":368,"type":21},"2027-08-30",{"name":370,"class":144},"SOFIE",15,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":388,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":44},"100642818","phase-1-the-0504-in-patients-with-solid-tumors-100642818","NCT07646106","THE-0504 in Patients With Solid Tumors","NANOFER-THE-0504: A Trial to Assess the Safety and Tolerability of an Investigational Drug THE-0504 for Patients With Solid Tumors","Inclusion Criteria:\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n1. written informed consent obtained;\n2. both gender adult (≥ 18 years) patients;\n3. diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative Breast Cancer (TNBrCa);\n4. measurable metastatic disease or locally advanced unresectable tumors;\n5. have exhausted all EMA-approved treatment options;\n6. ECOG Performance Status graded as 0 or 1;\n7. patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire trial (ability to attend all the planned trial visits according to the time limits included) based on Investigator's judgement;\n8. adequate liver function as assessed by following laboratory tests to be conducted within 28 days before the first dose of study treatment:\n\n   * Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for patients with documented Gilbert-Meulengracht Syndrome, or for patients with hyperbilirubinemia considered due to liver metastasis).\n   * Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor);\n9. adequate kidney function as assessed by following laboratory test to be conducted within 28 days before the first dose of study treatment:\n\n   • Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin per 1.73 m2 according to the CKD-EPI formula.\n10. adequate bone marrow function as defined as:\n\n    * Hgb ≥ 9 g\u002FdL\n    * ANC ≥1.5x109\u002FL\n    * PLT≥100.0 x109\u002FL\n11. Female patients of childbearing potential and male patients who are sexually active with women of childbearing potential will have to mandatorily use an appropriate method of contraception, according to the definition of Note 3 of ICH M3 Guideline, for the entire duration of the trial and for a minimum of 12 months after last administration of the IMP.\n\nExclusion Criteria:\n\nPatients will not be enrolled if they meet any of the following criteria:\n\n1. pregnant (as determined by a blood pregnancy test at the screening visit) or lactating women;\n2. male patients who are willing to father children during the trial or in the 12 months after the end of IMP administration;\n3. additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;\n4. have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enrol after agreement between the Investigator and Sponsor;\n5. ECOG Performance Status \\> 2;\n6. had not tolerated previously administered Top1 inhibitor treatments;\n7. known active CNS metastatic disease (patients with CNS metastases that are treated with radiotherapy and are stable for at least 28 days before study treatment start could be considered eligible);\n8. serious concurrent illness;\n9. Hgb \\\u003C 9 g\u002FdL;\n10. Transfusion dependent anemia with transfusion dependency of ≥3 months;\n11. Clinically significant iron metabolism disorders (e.g., sickle cell anemia) or use of iron chelators treatments;\n12. Iron overload, hereditary hemochromatosis and similar;\n13. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;\n14. Prolonged QTc interval;\n15. Multiple Sclerosis (MS) or other demyelinating disease, Eaton-Lambert syndrome, history of haemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;\n16. Non-healing wound(s), except for ulcerative lesions caused by the underlying neoplasm;\n17. History of severe allergic or anaphylactic reactions to previous protein-based therapy;\n18. Currently receiving anticoagulation therapy with warfarin;\n19. Known history of HIV infection, unless all the following are applicable:\n\n    * receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥ 3 months prior to the planned first study intervention;\n    * CD4 T-cell count \\> 350 cells\u002FμL\n    * CD4 T-cell nadir (lowest historical count) \\> 350 cells\u002FμL, and • viral load confirmed as \\\u003C 50 copies\u002FmL.\n20. HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable; and HCV infection, unless the participant has received curative treatment and viral load was confirmed as undetectable;\n21. Known autoimmune disease, uncontrolled diabetes, vitiligo, or stable thyroid disease;\n22. Patients on chronic (more than 10 days) administration of systemic, high-dose corticosteroids (≥4 mg Dexamethasone or equivalent), not amenable for reduction or suspension;\n23. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations;\n24. History of drugs and\u002For alcohol abuse;\n25. Patients considered to be unsuitable to participate, in the Investigator's opinion, for any other reason (e.g. consequences of previous medical and\u002For surgical procedures or other medical or ethical reasons);\n26. Planned relocation during the study, which would make impossible to attend the scheduled visits and follow-ups;\n27. Concomitant participation in other clinical trials or participation in the evaluation of any investigational drugs\u002Fproducts up to 4 weeks before this trial (in any case, enrolment procedure should start only after the complete washout of the drugs\u002Fproducts under investigation\\*\\*); or previous participation in the same trial or planned to receive other investigational products during the study.",{"count":380,"type":21},30,[120],"Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.",[384,385,31,386,387],"Small Cell Lung Cancer (SCLC)","Colorectal Carcinoma (CRC)","Triple -Negative Breast Cancer","Pancreas Adenocarcinoma",[389,390,391,392,393,394,395,396],"THE-0504","Solid tumors","Cancer","Single-centre","Thena Biotech","Italy","Phase 1","Europe","2026-06-09",{"date":399,"type":36},"2026-06-12",{"date":401,"type":36},"2024-11-13",{"date":403,"type":21},"2027-05-01",{"name":405,"class":144},"Thena Biotech S.r.l.",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":415,"type":21},146,[120],"The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[419,420,421,422,423,424,425,426,427,428,429,430,31,431,432],"Solid Tumours","Sarcoma","HNSCC","Non Small Cell Lung Cancer","NSCLC","Colorectal Cancer (CRC)","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma",{"date":434,"type":36},"2026-06-11",{"date":436,"type":36},"2025-01-23",{"date":438,"type":21},"2028-09",{"name":440,"class":144},"Epkin",10,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":44},"100643800","comparison-of-double-tract-and-tubular-gastric-anastomosis-in-proximal-gastric-cancer-100643800","NCT07635836","Comparison of Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer","Comparison of Gastroesophageal Reflux and Quality of Life Between Double-tract and Tubular Gastric Anastomosis in Proximal Gastric Cancer Patients","Inclusion Criteria:\n\n* Pathologically confirmed gastric adenocarcinoma by biopsy\n* Carcinoma of the upper gastric body or Siewert type II\u002FIII adenocarcinoma of the esophagogastric junction (AEG), with a clinical stage of cT1-3N0-1M0\n* Age 18-75 years, with a performance status (PS) score of 0-2\n* Candidates for planned surgical resection, eligible for either double-tract reconstruction or tubular gastric anastomosis based on preoperative assessment\n* No severe dysfunction of vital organs (liver, kidney, heart, lung, or brain), and no severe infection or uncontrolled chronic diseases\n\nExclusion Criteria:\n\n* Presence of other malignant tumors or severe chronic diseases (e.g., severe diabetes mellitus, chronic kidney disease, decompensated cirrhosis, etc.)\n* Preoperative endoscopic diagnosis of Barrett's esophagus\n* Severe preoperative malnutrition (albumin \\\u003C30 g\u002FL, prealbumin \\\u003C150 mg\u002FL)\n* History of prior upper abdominal surgery, gastrointestinal malformation, or psychiatric disorders\n* Preoperative diagnosis of obstructive motor disorders of the cardia (including achalasia spectrum disorders)\n* Inability to cooperate with or complete the required postoperative examinations",{"count":450,"type":21},52,[155],"This study includes patients diagnosed with proximal gastric cancer (Siewert type II\u002FIII, cT1-3N0-1M0) across six tertiary hospitals, who underwent either double-tract reconstruction (DTR) or tubular gastric anastomosis (TGA). Participants were divided into two groups based on the surgical procedure. We conducted a comparative analysis of postoperative outcomes by evaluating electronic medical records, postoperative gastroscopy, 24-hour esophageal pH monitoring, and relevant rating scales.",[31,454,455],"Double-tract Reconstruction","Tubular Gastric Anastomosis","2026-06-03",{"date":397,"type":36},{"date":459,"type":36},"2026-05-01",{"date":461,"type":21},"2027-10-01",{"name":463,"class":43},"Qilu Hospital of Shandong University",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":87,"sex":16,"minAge":471,"maxAge":4,"enrollmentInfo":472,"targetDuration":474,"studyType":90,"phases":4,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":4},"100637944","ai-based-risk-prediction-model-for-upper-digestive-tract-cancer-100637944","NCT07605312","AI-Based Risk Prediction Model for Upper Digestive Tract Cancer","Development of Artificial Intelligence Risk Prediction Model for Upper Digestive Tract Cancer Using High Resolution Endoscopic Image, Digital Pathology, Genetics, and Oro-gastro-intestinal Microbiota.","Inclusion Criteria:\n\n* Patients undergoing upper gastrointestinal endoscopy.\n* Patients with at least one of the following conditions or indications:\n\n  * Previous or current Helicobacter pylori infection (confirmed by serology, histopathology, urea breath test, rapid urease test, or stool antigen test);\n  * Dyspeptic symptoms;\n  * Gastroesophageal reflux disease;\n  * History of oral, oropharyngeal, or hypopharyngeal squamous cell carcinoma;\n  * Barrett's esophagus;\n  * Gastric premalignant lesions (intestinal metaplasia or atrophic gastritis);\n  * Gastric subepithelial lesions.\n\nExclusion Criteria:\n\n\\-","40 Years",{"count":473,"type":21},10000,"10 Years","Upper digestive tract cancers are often preceded by pre-malignant lesions, but there is limited evidence regarding optimal risk prediction models and screening strategies for disease progression and cancer development. This prospective multicenter cohort study aims to establish a longitudinal database integrating clinical information, endoscopic findings, pathology, genetics, epigenetics, and gastrointestinal microbiota data from subjects undergoing upper digestive tract endoscopy.\n\nThe study will develop explainable artificial intelligence (AI)-based risk prediction models to identify factors associated with disease progression, treatment response, and cancer development. Participants will be followed longitudinally to evaluate changes in lesion severity and clinical outcomes.",[31,477,478,96,98,479],"Premalignant Lesion","Gastric Intestinal Metaplasia","Esophageal Cancer (EsC)","2026-05-25",{"date":482,"type":36},"2026-05-28",{"date":484,"type":21},"2026-05-18",{"date":486,"type":21},"2030-05-18",{"name":488,"class":43},"National Taiwan University Hospital",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":176,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":510,"locationsCount":44},"100637359","a-study-on-the-efficacy-of-sodium-propionate-combined-with-anti-pd-1-immunotherapy-in-gastric-cancer-100637359","NCT07615907","A Study on the Efficacy of Sodium Propionate Combined With Anti-PD-1 Immunotherapy in Gastric Cancer","Sodium Propionate Combined With Anti-PD-1 Immunotherapy on Tumor Efficacy in Gastric Cancer Patients","PAPGC","Inclusion Criteria:\n\n* Subjects voluntarily participated in the trial and signed the informed consent form;\n* Aged ≥ 18 years and \\\u003C 80 years, regardless of gender;\n* Stable vital signs;\n* Patients with gastric adenocarcinoma confirmed by gastroscopic biopsy;\n* Tumors judged as unresectable by attending physicians;\n* Receiving anti-PD-1 therapy combined with chemotherapy as first-line treatment;\n* No history of allergic diseases and non-allergic constitution;\n* No history of drug abuse;\n* Non-pregnant and non-lactating females (applicable to male subjects as well);\n* No participation in any drug clinical trial (including investigational drugs of this trial) within 3 months prior to enrollment.\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria, or individuals deemed inappropriate for trial participation by investigators;\n* Concurrent primary malignant tumors at other sites;\n* Poor general condition, severe infection, respiratory insufficiency, or other conditions leading to inability to cooperate with the trial;\n* Patients with mental disorders, consciousness disturbance, or poor treatment compliance;\n* Suspected or confirmed history of drug abuse;\n* Immunodeficiency, or long-term use of immunosuppressants and glucocorticoids;\n* Pregnant or lactating women;\n* Sponsors, investigators directly involved in this trial, and their immediate family members;\n* Individuals unsuitable for enrollment for any reason as judged by the investigator.",{"count":498,"type":21},20,[155],"Eligible patients were randomized into two groups: the sodium propionate group and the control group. In the control group, patients received placebo combined with anti-PD-1 therapy plus chemotherapy without additional sodium propionate intervention. In the sodium propionate group, on the basis of anti-PD-1 therapy combined with chemotherapy, patients were additionally administered oral sodium propionate capsules at a dose of 500 mg (1 capsule) twice weekly, with a total intervention duration of 12 weeks. The primary and secondary outcome indicators will be collected for subsequent analysis.",[31],[503,504,158],"Gastric cancer","Sodium propionate",{"date":506,"type":36},"2026-05-29",{"date":508,"type":21},"2026-05-30",{"date":368,"type":21},{"name":511,"class":43},"Jinling Hospital, China",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":519,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100639609","phase-1-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-xh001-injection-as-adjuvant-therapy-in-patients-with-high-risk-recurrent-solid-tumors-100639609","NCT07594964","To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors","Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors After Radical Surgery","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form;\n* Aged between 18 and 70 years old, male or female;\n* Patients with high-risk recurrent solid tumors confirmed by pathology after radical surgery mainly include pancreatic ductal adenocarcinoma, biliary tract malignancies, hepatocellular carcinoma, gastric adenocarcinoma, etc.\n* Expected survival duration ≥12 months;\n* ECOG score of 0-1;\n* White blood cell count≥ 3.0×10\\^9\u002FL; Neutrophil count ≥ 1.0×10\\^9\u002FL; Platelet count ≥75×10\\^9\u002FL; Hemoglobin (Hb)≥ 90g\u002FL; Creatinine clearance rate≥50mL\u002Fmin \\[calculated using the Cockcroft-Gault formula\\]; Alanine aminotransferase ≤ 3×ULN (patients with hepatocellular carcinoma or biliary tract malignancy \\\u003C5×ULN); Aspartate aminotransferase ≤ 3×ULN ((patients with hepatocellular carcinoma or biliary tract malignancy \\\u003C5×ULN); Total bilirubin ≤ 3×ULN; Serum albumin \\> 28g\u002FL; Coagulation: Prothrombin time prolongation ≤ 4s;\n\nExclusion Criteria:\n\n* There is evidence of tumor residue, recurrence or metastasis during screening;\n* Has a history of hepatic encephalopathy or liver transplantation;\n* Has clinical uncontrolled (requiring repeated drainage) pericardial effusion, pleural effusion and moderate or severe ascites;\n* Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (\\>=Grade 3) to XH001 injection and\u002For any of its excipients;\n* New cerebrovascular accidents within 6 months before screening (including ischemic stroke, hemorrhagic stroke and transient ischemic attack)；\n* Individuals who have experienced acute myocardial infarction, or have uncontrolled angina pectoris, uncontrolled arrhythmia, severe heart failure (NYHA heart failure classification standard\\>= Grade III) and other cardiovascular diseases within 6 months before screening;\n* Patients with pancreatic ductal adenocarcinoma (PDAC) have the following conditions: 1) Borderline resectable pancreatic ductal adenocarcinoma; 2) Tumor tissue containing neuroendocrine tumor components (i.e., mixed type); 3) Pancreatic tumor types other than PDAC; 4) Persistent severe diarrhea after surgery;\n* Patients with biliary tract malignancy have the following conditions: 1) Pancreatic or ampullary cancer; 2) Unresolved biliary obstruction; 3) Insufficient surgical biliary drainage, and there are signs of infection;\n* .Subjects with hepatocellular carcinoma exhibit the following conditions: 1) The tumor contains components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and biliary tract malignancy; 2) Received more than one cycle of adjuvant TACE after surgery or ablation;\n* Patients with gastric adenocarcinoma have the following conditions: severe postoperative complications (severe postoperative infection, anastomotic leakage and gastrointestinal bleeding);\n* Have active or poorly controlled severe infections;\n* .Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma;\n* Any history of autoimmune diseases (regardless of whether they are currently active),；\n* Who have previously received similar therapeutic tumor vaccines;","70 Years",{"count":521,"type":21},48,[120],"The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery.\n\nThe main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?",[525,215,249,31],"Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)",[527,528],"mRNA","Neoantigen specific tumor vaccine",{"date":530,"type":36},"2026-05-19",{"date":532,"type":36},"2025-08-25",{"date":534,"type":21},"2030-06-30",{"name":536,"class":144},"Shenzhen Xinhe Biomedical",2,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":547,"conditions":548,"keywords":551,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":561,"leadSponsor":563,"locationsCount":4},"100638271","a-subharmonic-aided-pressure-estimate-technology-for-prediction-of-response-to-systemic-therapy-in-gastric-cancer-liver-metastases-100638271","NCT07581730","A Subharmonic-Aided Pressure Estimate Technology for Prediction of Response to Systemic Therapy in Gastric Cancer Liver Metastases","A Prospective Study of a Subharmonic-Aided Pressure Estimate Technology for Early Prediction of Response to Systemic Therapy in Gastric Cancer Liver Metastases","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or radiologically confirmed, initially diagnosed and have not undergone any treatment gastric liver metastasis (GCLM).\n* Lesion size ≤ 6 cm (preferably located adjacent to major anatomical structures such as large vessels or bile ducts).\n* Lesion depth ≤ 10 cm on ultrasound imaging.\n* Planned to receive guideline-recommended first-line systemic therapy.\n* The target lesion has not undergone any prior systemic or local treatment, including surgery, ablation, embolization, targeted therapy, or investigational agents, before enrollment.\n* Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to cooperate with contrast-enhanced ultrasound or subharmonic imaging examinations (e.g., dyspnea when lying supine or excessive out-of-plane motion).\n* Know or suspected allergy to the contrast agent or other contraindications to its use.\n* Target lesion not previously evaluated or managed according to standard systemic treatment protocols.\n* Clinically unstable condition, advanced-stage disease, or patients with an unpredictable clinical course that may affect treatment tolerance or follow-up.\n* Pregnant or breastfeeding women. 6.Inability to understand or comply with the study protocol, including the requirement to complete follow-up visits and examinations.",{"count":546,"type":21},107,"Gastric cancer is a common type of cancer that often spreads to the liver. When cancer spreads to the liver, treatment becomes very difficult. Many patients will undergo chemotherapy to shrink the tumor. Currently, doctors use CT or MRI scans to assess the effect of chemotherapy, but these examinations usually take about 2 months to show changes in the size of the tumor.\n\nThe purpose of this study is to test whether a special type of ultrasound technology called \"contrast-enhanced subharmonic ultrasound\" can help doctors determine earlier whether chemotherapy is effective compared to conventional scans. This ultrasound detection does not use radiation and can display the blood perfusion status inside liver tumors. We will observe the changes in blood flow perfusion inside the tumor before the start of treatment and after 1-2 chemotherapy cycles to see if these changes can predict whether chemotherapy will be effective in the future.\n\nIf this test is effective, it will help doctors adjust the treatment plan more quickly, which may improve the treatment effect for gastric cancer patients whose cancer cells have spread to the liver, and also help identify patients who are not responding to chemotherapy as early as possible, reducing the side effects and economic burden of patients.",[549,31,550],"Liver Neoplasms","Gastric Cancer Metastatic to Liver",[552,553,554,555,556,557],"Gastric cancer liver metastasis","Contrast-enhanced ultrasound","Subharmonic imaging","Chemotherapy response prediction","Early treatment response","Perfusion imaging",{"date":559,"type":36},"2026-05-20",{"date":459,"type":21},{"date":562,"type":21},"2027-12-01",{"name":564,"class":43},"The First Hospital of Jilin University",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":592},"100623789","multimodal-ai-for-predicting-response-to-neoadjuvant-immunotherapy-in-gastric-cancer-prism-gc-100623789","NCT07401199","Multimodal AI for Predicting Response to Neoadjuvant Immunotherapy in Gastric Cancer (PRISM-GC)","A Prospective, Multicenter, Real-World Cohort Study for the Development and Validation of a Multimodal Artificial Intelligence System to Predict Response to Neoadjuvant Chemo-Immunotherapy in Locally Advanced Gastric Cancer (The PRISM-GC Study)","Inclusion Criteria:\n\nAge ≥ 18 years.\n\nHistologically confirmed gastric or gastroesophageal junction adenocarcinoma.\n\nClinical stage cT3-4a, N+, M0 (locally advanced) assessed by CT\u002FMRI and endoscopic ultrasound.\n\nScheduled to receive neoadjuvant chemotherapy combined with PD-1 inhibitors (regimens including but not limited to SOX\u002FXELOX + Sintilimab\u002FTislelizumab\u002FCamrelizumab, etc.) as standard of care.\n\nAvailability of standard pre-treatment contrast-enhanced abdominal CT images.\n\nWillingness to provide peripheral blood samples and tumor tissue (biopsy\u002Fsurgical) for sequencing and analysis.\n\nECOG performance status 0-1.\n\nAdequate organ function to tolerate systemic chemotherapy.\n\nExclusion Criteria:\n\nEvidence of distant metastasis (Stage IV) or unresectable disease.\n\nPrevious systemic anti-tumor therapy for gastric cancer (chemotherapy, radiotherapy, or immunotherapy).\n\nHistory of other malignancies within the past 5 years.\n\nActive autoimmune diseases requiring systemic immunosuppressive treatment (contraindication for PD-1 inhibitors).\n\nEmergency surgery due to obstruction, perforation, or uncontrolled bleeding.\n\nSevere metallic artifacts on CT images that interfere with radiomic feature extraction.\n\nPregnancy or lactation.",{"count":573,"type":21},2000,"Gastric cancer is a major global health challenge. Currently, a combination of chemotherapy and immunotherapy (PD-1 inhibitors) is frequently used before surgery to shrink tumors, a strategy known as neoadjuvant therapy. While this approach is effective for many patients, responses vary significantly, and there are currently no reliable tools to predict which patients will benefit the most before treatment begins.\n\nThe PRISM-GC study aims to develop and validate a novel Artificial Intelligence (AI) system to address this need. This is a prospective, observational study that will collect data from patients diagnosed with locally advanced gastric cancer who are scheduled to receive standard neoadjuvant chemotherapy combined with immunotherapy in a real-world clinical setting. The specific choice of immunotherapy drug is determined by the treating physician and is not dictated by the study.\n\nResearchers will analyze standard preoperative CT scans and pathological tissue slides using advanced deep learning algorithms. The goal is to create a \"multimodal\" AI model that can accurately predict how well a tumor will respond to treatment (specifically, whether the tumor will disappear or shrink significantly). If successful, this AI tool could help doctors personalize treatment plans in the future, ensuring that each patient receives the most effective therapy while avoiding unnecessary side effects.",[31,576],"Locally Advanced Gastric Cancer",[578,579,580,581,582],"Neoadjuvant Immunotherapy","Artificial Intelligence","Deep Learning","Pathological Complete Response","PD-1 Inhibitors","2026-05-13",{"date":585,"type":36},"2026-05-15",{"date":587,"type":36},"2026-02-05",{"date":589,"type":21},"2027-12-30",{"name":591,"class":43},"Qun Zhao",9,{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":4},"100639312","prediction-of-peritoneal-dissemination-of-digestive-tumors-through-the-study-of-circulating-tumor-dna-100639312","NCT07574957","Prediction of Peritoneal Dissemination of Digestive Tumors Through the Study of Circulating Tumor DNA","Prédiction de la dissémination péritonéale Des Tumeurs Digestives Par étude de l'ADN Tumoral Circulant","PREDIPER","Inclusion Criteria:\n\n* Age \\> 18 years\n* Signed non-opposition form\n* For gastric cancer: histologically confirmed gastric adenocarcinoma \\>T2 and\u002For N+; for colon cancer: histologically confirmed colonic adenocarcinoma \\>T2; for pancreatic cancer: histologically confirmed pancreatic adenocarcinoma \\>T2\n* No metastases on the initial staging work-up\n* No contraindication to curative-intent surgical treatment\n\nExclusion Criteria:\n\n* Primary tumor metastatic at diagnosis\n* Presence of ascites or distant metastases\n* Synchronous cancer or prior history of cancer within the past 5 years\n* Contraindication to curative surgical treatment\n* Any patient unable to comply with the study's medical follow-up for geographic, social, or psychological reasons\n* Patients under legal guardianship\u002Fprotection, or unable to read, understand, and sign the information notice and consent form\n* Patients not affiliated with the social security system",{"count":178,"type":21},"The peritoneum is a relatively frequent metastatic site in digestive tumors (colon, stomach, pancreas) and is characterized by a poorer prognosis compared with other metastatic sites such as the lung or liver. Its dissemination pathway is complex and most often involves crossing the hemato-peritoneal barrier. This type of metastasis is difficult to visualize on imaging at an early stage, and surgical exploration may be required. In gastric cancer in particular, exploratory laparoscopy is part of the initial staging work-up for locally advanced tumors to assess the presence or absence of peritoneal metastases. It is therefore important to develop new, less invasive detection or prediction methods.\n\nCirculating tumor DNA (ctDNA) is a promising non-invasive blood biomarker that can assist clinicians as a prognostic\u002Fpredictive biomarker and\u002For a tool for monitoring response to anti-tumor therapies. This marker is most often assessed in plasma, but recent data suggest that tumor DNA may also be detected in other biological fluids such as peritoneal fluid. A preliminary study conducted by our team showed the ability to detect tumor DNA in peritoneal fluid from patients with peritoneal carcinomatosis of various origins, with a sensitivity of 75%. In gastric cancer, a recent meta-analysis demonstrated an increased risk of peritoneal metastases when peritoneal tumor DNA was positive (RR 13.81 \\[95% CI, 8.11-23.53\\]), as well as a reduction in 3-year recurrence-free survival (RR 5.37 \\[95% CI, 1.39-20.74\\]) and overall survival (HR 4.13 \\[95% CI, 1.51-11.32\\]).\n\nThe objective of this cohort is to evaluate the prognostic impact of circulating tumor DNA (ctDNA) in plasma and\u002For peritoneal fluid on the risk of developing peritoneal metastases. The primary endpoint is: Peritoneal recurrence rate according to tumor DNA positivity status (positive vs negative).",[31,604,123],"Pancreatic Cancer","2026-05-05",{"date":607,"type":36},"2026-05-08",{"date":609,"type":21},"2026-06-01",{"date":611,"type":21},"2033-06-01",{"name":613,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":623,"conditions":624,"keywords":627,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":44},"100626911","immediate-and-functional-results-of-different-types-of-reconstructions-after-proximal-gastrectomy-for-gastric-and-esophagogastric-junction-cancer-100626911","NCT07441785","Immediate and Functional Results of Different Types of Reconstructions After Proximal Gastrectomy For Gastric and Esophagogastric Junction Cancer","PROXISTAT","Inclusion Criteria:\n\n* All consecutive patients with clinically documented primary Gastric or Esophagogastric Junction malignancy (including Siewert I and II) cT1-3N0-2M0 undergoing proximal gastrectomy with curative intent - via open, laparoscopic or robotic approach between 01th January 2025 and 31th December 2026\n\nExclusion Criteria:\n\n* Patients with clinical evidence of metastatic disease, including positive peritoneal cytology on a previous staging laparoscopy, or those with known synchronous other cancers.\n* Esophagogastric Junction Siewert I malignancy\n* Patients submitted to Emergency surgery or surgery without curative intent\n* Patients undergoing any other surgery in addition to the curative surgery for primary Esophageal or Esophagogastric Junction malignancy\n* Patients who have previously undergone surgery on the stomach or colon",{"count":622,"type":21},400,"Proximal gastric and esophagogastric junction cancers comprise up to 40% of gastric malignancies. For localized disease, proximal gastrectomy is the main radical procedure, but reconstruction of GI tract often leads to significant functional issues.\n\nRising use of proximal resections and broader indications have increased attention to postoperative quality of life (QoL). Common reconstructions include direct esophagogastrostomy (various types), double-tract reconstruction, jejunal interposition, and newer anti-reflux anastomoses (e.g., double-flap, overlap, tunnel techniques).\n\nEach method has unique pros and cons regarding reflux esophagitis, food passage, dumping syndrome, nutritional changes, and long-term QoL.\n\nNo consensus exists on the optimal technique, leading to variable practices and outcomes. Most research focuses on oncologic radicality and survival, while functional results and QoL remain understudied.\n\nSystematic evaluation of functional outcomes across reconstruction types after proximal subtotal gastrectomy is needed in Russian Federation to improve QoL, advance research, and standardize treatment of proximal gastric and EGJ cancers.",[31,625,626],"Siewert Type III Adenocarcinoma of Esophagogastric Junction","Siewert Type II Adenocarcinoma of Esophagogastric Junction",[628,629,630,631,632,633],"Proximal gastrectomy","Morbidity","Mortality","Quality of life","Surgery","Esophagogastric Junction Cancer","2026-04-17",{"date":636,"type":36},"2026-04-22",{"date":638,"type":36},"2025-01-01",{"date":640,"type":21},"2029-06-01",{"name":642,"class":168},"P. Herzen Moscow Oncology Research Institute",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":650,"targetDuration":4,"studyType":22,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":4},"100632587","phase-2-efficacy-of-sintilimab-combined-with-bevacizumab-and-xeloxsox-in-initially-unresectable-afp-positive-gastricgastroesophageal-junction-adenocarcinoma-100632587","NCT07515625","Efficacy of Sintilimab Combined With Bevacizumab and XELOX\u002FSOX in Initially Unresectable AFP-positive Gastric\u002FGastroesophageal Junction Adenocarcinoma","Conversion Therapy of Sintilimab Combined With Bevacizumab and XELOX\u002FSOX for Initially Unresectable AFP-positive Gastric\u002FEsophagogastric Junction Adenocarcinoma : A Multi-center, Single-arm, Phase II Trial (SOLIDS-02)","Inclusion Criteria:\n\n* Signed informed consent;\n* Patients age 18-75 years;\n* Histologically CT\u002FMRI confirmed cT3-4N+M0\u002F1 gastric or GEJ adenocarcinoma; (M1 only includes type I liver metastasis of gastric cancer, according to the \"Chinese Expert Consensus on Liver Metastasis of Gastric Cancer\");\n* Serum AFP levels \\> 2× upper limit of normal or AFP-positive by IHC staining;\n* Adequate organ function\n* ECOG 0-1, no surgery contraindications;\n* Expected survival ≥3 months;\n\nExclusion Criteria:\n\n* HER2-positive status: IHC 3+, or IHC 2+\u002FFISH+\n* Prior chemotherapy, radiotherapy, anti-PD-1\u002FPD-L1 therapy, surgery for gastric cancer;\n* Signs of other distant metastases (e.g., peritoneal, lung, bone, supraclavicular lymph, etc.)\n* Significant cardiovascular disease\n\n  --Current treatment with anti-viral therapy or HBV\n* Pregnancy or breastfeeding\n* History of malignancy within 5 years prior to screening\n* Present or history of any autoimmune disease or immune deficiency;\n* There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors.",{"count":651,"type":21},46,[24],"Alpha-fetoprotein-producing gastric cancer (AFP-positive gastric cancer, AFP-GC), a rare and highly aggressive subtype of gastric cancer, accounts for 1.3% to 15% of all gastric cancer cases. Its clinical features are significantly different from those of common gastric cancer. Not only does it show abnormally elevated serum AFP levels, but it also has a stronger angiogenic ability, a higher rate of distant metastasis, and a poorer prognosis even after a upfront R0 surgery, making it a challenging problem in the field of gastric cancer treatment. Notably, patients with AFP-positive gastric cancer have a relatively low sensitivity to the traditional standard regimens. There is an urgent need to explore targeted treatment strategies to break through the efficacy bottleneck.\n\nCombination of sintilimab, bevacizumab and XELOX\u002FSOX for initially unresectable AFP-positive gastric\u002Fesophagogastric junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a multi-center, single-arm phase 2 clinical trial to evaluate efficacy, tolerability and safety of perioperative sintilimab in combination with bevacizumab and XELOX\u002FSOX in initially unresectable AFP-positive gastric\u002Fesophagogastric junction adenocarcinoma.",[31,655],"AFP Gastric or Gastroesophageal Junction Adenocarcinoma","2026-03-30",{"date":658,"type":36},"2026-04-07",{"date":660,"type":21},"2026-04-01",{"date":662,"type":21},"2029-04-01",{"name":664,"class":43},"Fudan University",{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":681,"leadSponsor":683,"locationsCount":4},"100631541","phase-4-a-clinical-study-of-iparomlimab-and-tuvonralimab-combined-with-sox-following-heterogeneous-radiotherapy-as-first-line-treatment-for-unresectable-locally-advanced-or-metastatic-her2-negative-gastric-or-gastroesophageal-junction-adenocarcinoma-100631541","NCT07502027","A Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma","A Multicenter, Single-arm, Exploratory Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Age 18-75 years, male or female.\n* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.\n* Patients with no prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. For patients who received neoadjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent, the interval from the last treatment to disease progression must be at least 6 months.\n* HER-2 negative (IHC 1+ or IHC 2+\u002FFISH-negative).\n* Presence of radiation-eligible tumor lesions.\n* No anticipated need for tumor resection during the study treatment period.\n* ECOG performance status 0-1.\n* At least one measurable lesion per RECIST v1.1. Lesions that have received prior radiotherapy cannot be selected as target lesions unless they are the only measurable lesions and show unequivocal progression on imaging, in which case they may be considered as target lesions.\n* Expected overall survival ≥ 3 months.\n* Adequate function of major organs.\n\nExclusion Criteria:\n\n* Presence of other histologic components confirmed by histopathology or cytology, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc.\n* Prior treatment with any tumor immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or immune cell therapy (e.g., CAR-T cells).\n* Palliative local therapy to non-target lesions within 2 weeks before the first dose; or systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin) within 2 weeks before the first dose.\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time per month).\n* Known active or untreated brain metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease. Patients with measurable lesions outside the central nervous system may be eligible if: they are asymptomatic after treatment, radiologically stable for at least 4 weeks before study treatment (no new or enlarging brain metastases), and have discontinued systemic corticosteroids and anticonvulsants for at least 2 weeks.\n* Gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months before the first dose.\n* Clinically significant bleeding or definite bleeding diathesis within 6 months before the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, excluding asymptomatic positive fecal occult blood.\n* Arterial or venous thromboembolism within 6 months before the first dose, including cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc. Superficial venous thrombosis is permitted.\n* Clinically active hemoptysis or active diverticulitis.\n* Major surgery other than for gastric cancer diagnosis within 28 days before the first dose, or anticipated major surgery during the study period.\n* Severe infection (CTCAE grade \\> 2) within 4 weeks before the first dose, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; active lung inflammation on baseline chest imaging; or signs\u002Fsymptoms of infection or oral\u002Fintravenous antibiotic therapy within 14 days before the first dose, excluding prophylactic antibiotics.\n* Any active or history of autoimmune disease, including but not limited to: interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism. Hypothyroidism may be allowed if controlled by hormone replacement. Patients with fully resolved psoriasis or childhood asthma\u002Fallergies requiring no intervention in adulthood may be included; those requiring medical intervention with bronchodilators are excluded.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation.\n* Uncontrolled cardiac conditions, including but not limited to:\n\n  1. NYHA class ≥ II heart failure;\n  2. unstable angina;\n  3. myocardial infarction within 1 year;\n  4. clinically significant supraventricular or ventricular arrhythmia uncontrolled or poorly controlled despite intervention;\n  5. QTc \\> 450 ms (male); QTc \\> 470 ms (female).\n* Active tuberculosis confirmed by medical history or CT scan, active tuberculosis within 1 year before screening, or history of active tuberculosis \\> 1 year without standard treatment.\n* Active hepatitis: HBsAg positive with HBV DNA ≥ 2000 IU\u002FmL; HCV antibody positive with HCV viral load above the upper limit of normal.\n* Diagnosis of another malignancy within 5 years before the first dose, except malignancies with low risk of metastasis or death (5-year survival \\> 90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Administration of live attenuated vaccine within 4 weeks before the first dose. If enrolled, patients must not receive live vaccines during the study or within 120 days after the last dose of iparomlimab and tuvonralimab.\n* Known hypersensitivity or intolerance to any study drug(s) and\u002For their components.\n* Toxicity from prior anti-tumor therapy that has not resolved to NCI-CTCAE v5.0 grade 0 or 1, or to the level specified in the inclusion\u002Fexclusion criteria, except alopecia or pigmentation.\n* Pregnant or lactating female.\n* Participation in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.\n* Any other conditions judged by the investigator that may result in premature discontinuation from the study, including other severe diseases (including psychiatric disorders) requiring concurrent treatment, alcoholism, drug abuse, family or social factors that may affect patient safety or compliance.",{"count":673,"type":21},55,[57],"This study is a domestic, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of heterogeneous radiotherapy (high and low dose) sequenced with iparomlimab and tuvonralimab plus SOX as a first-line treatment for unresectable locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.",[677,31,324],"Gastric Cancer (Diagnosis)","2026-03-24",{"date":656,"type":36},{"date":609,"type":21},{"date":682,"type":21},"2029-06-30",{"name":684,"class":43},"Huazhong University of Science and Technology",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":695,"conditions":696,"keywords":701,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":4},"100627804","phase-1-qls5132-combination-therapy-in-advanced-solid-tumors-100627804","NCT07453394","QLS5132 Combination Therapy in Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Advanced solid tumors;\n2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n4. Adequate organ function;\n5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.\n\nExclusion Criteria:\n\n1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates \\[ADCs\\]), or any drug containing topoisomerase I inhibitors (including ADCs);\n2. Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;\n3. Progressive or symptomatic brain metastases;\n4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;\n5. History of significant cardiac disease, or poorly controlled diabetes mellitus;\n6. History of recurrent autoimmune diseases;\n7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);\n8. History of a second primary malignancy;\n9. If female, is pregnant or breastfeeding;\n10. Be allergic to any component of QLS5132 or its excipients.",{"count":693,"type":21},626,[120,24],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.\n\nThe main questions it aims to answer are:\n\n* In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?\n* In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?\n\nParticipants will:\n\n* Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.\n* Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.",[31,697,698,699,700],"Non-small Cell Lung Cancer (NSCLC)","Endometrial Cancer","Advanced Solid Tumors","Ovarian Cancer",[702],"CLDN6 ADC","2026-03-04",{"date":705,"type":36},"2026-03-06",{"date":707,"type":21},"2026-04",{"date":709,"type":21},"2029-02",{"name":711,"class":144},"Qilu Pharmaceutical Co., Ltd.",{"id":713,"slug":714,"hasResults":12,"nctId":715,"briefTitle":716,"officialTitle":717,"acronym":4,"eligibilityCriteria":718,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":719,"targetDuration":4,"studyType":22,"phases":720,"briefSummary":721,"conditions":722,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":730,"completionDateStruct":732,"leadSponsor":734,"locationsCount":44},"100622993","phase-1-a-study-of-sh009-injection-in-patients-with-advanced-solid-tumors-100622993","NCT07390838","A Study of SH009 Injection in Patients With Advanced Solid Tumors.","An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n* (1) Age≥18 years old at the time of informed consent, male or female;\n* (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;\n* (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;\n* (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;\n* (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;\n* (6) Life expectancy ≥12 weeks;\n* (7) Bone marrow function meets the following criteria: neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 90 × 10\\^9\u002FL (platelet count ≥ 75 × 10\\^9\u002FL in patients with liver cancer); hemoglobin (Hb) ≥ 90 g\u002FL;\n* (8) Liver function meets the following criteria: total bilirubin(TBIL) ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT) ≤ 3 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver cancer or liver metastases);\n* (9) Renal function meets the following criteria: serum creatinine clearance(CLcr) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula); urine dipstick test results show that urine protein \\\u003C 2 +, urine protein ≥ 2 + subjects should undergo 24-hour urine collection and urine protein content \\\u003C 1g within 24 hours;\n* (10) Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN;\n* (11) Female subjects of childbearing potential must use effective contraception during the trial and for 6 months after the last dose, and have a negative pregnancy test within 7 days before treatment initiation (except those who are surgically sterilized or postmenopausal). Male subjects must agree to use effective contraception during the trial and for 6 months after the last dose;\n* (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.\n\nExclusion Criteria:\n\n* (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47\u002FSIRPα recombinant protein;\n* (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;\n* (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese\u002Fherbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;\n* (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;\n* (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period;\n* (6) Patients who received systemic glucocorticoids (dexamethasone \\> 10 mg\u002F day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast allergy);\n* (7) Symptomatic brain parenchymal or leptomeningeal metastases, deemed by the investigator as unsuitable for enrollment;\n* (8) Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis;\n* (9) Severe or uncontrolled systemic disease, including but not limited to: uncontrolled pleural or peritoneal effusion; uncontrolled diabetes; ventricular arrhythmia requiring intervention; acute coronary syndrome, congestive heart failure, stroke, or other ≥Grade 3 cardiovascular event within 6 months; NYHA Class ≥II or LVEF \\\u003C50%; clinically significant QTcF prolongation or arrhythmia risk (baseline QTcF \\>450 msec for males or \\>470 msec for females); clinically uncontrolled hypertension (SBP \\>160 mmHg and\u002For DBP \\>90 mmHg after treatment) as judged by the investigator. Subjects judged by the investigator as unsuitable due to any such condition;\n* (10) History of pneumonia requiring hormone therapy or interstitial lung disease (including past and current history); active pulmonary infection;\n* (11) Active infection requiring intravenous anti-infective therapy within 1 week prior to study drug administration (fever attributed to the tumor per investigator's judgment is acceptable). History of self-limited infections that have resolved is acceptable;\n* (12) Active Hepatitis B, Hepatitis C, or syphilis infection. Subjects positive for HBeAb or HBsAg are eligible if HBV-DNA ≤200 IU\u002FmL. Subjects positive for HCV-Ab are eligible if HCV-RNA ≤ the upper limit of normal at the research center. Subjects with hepatocellular carcinoma and HBV-DNA ≥2000 IU\u002FmL must receive antiviral\u002Fhepatoprotective therapy first and can only enroll after HBV-DNA decreases to \\\u003C2000 IU\u002FmL;\n* (13) History of primary immunodeficiency, including positive human immunodeficiency virus (HIV) test, or suffering from other acquired, congenital immunodeficiency diseases;\n* (14) History of other malignancies within 5 years prior to the first dose, except for:\n\n  a) Any other invasive malignancy, treated with curative intent, with a disease-free interval \\>3 years and deemed by the investigator not to affect efficacy evaluation for the current tumor. b) Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or other locally cured cancers;\n* (15) History or presence of autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis or high risk (e.g., post-transplant immunosuppression). Exceptions: stable type 1 diabetes on fixed-dose insulin; autoimmune hypothyroidism on hormone replacement only; skin conditions not requiring systemic treatment (e.g., eczema, rash covering\\\u003C10% BSA, psoriasis without ocular symptoms);\n* (16) Arterial thromboembolic events within 6 months prior to the first dose, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose (catheter-related or superficial venous thrombosis is not considered \"serious\"). Receiving thrombolytic or anticoagulant therapy for high thrombotic risk;\n* (17) Subjects who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant);\n* (18) According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss, pigmentation, hypothyroidism stabilized by hormone replacement therapy and peripheral neuropathy (need to recover to ≤ grade 2)). Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the study drug may be allowed after consultation with the medical monitor;\n* (19) Known history of severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies(CTCAE v5.0 Grade ≥3), or any component of the study drug;\n* (20) Known alcohol and\u002For drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment, including but not limited to psychiatric disorders;\n* (21) Pregnant or lactating women.",{"count":89,"type":21},[120],"Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors",[723,724,725,726,30,31,727],"Liver Cancer (Locally Advanced or Metastatic)","Lung Cancer (NSCLC)","Head and Neck Cancer Squamous Cell Carcinoma","Breast Cancer (Locally Advanced or Metastatic)","Solid Tumor Malignancies","2026-01-28",{"date":587,"type":36},{"date":731,"type":36},"2025-05-16",{"date":733,"type":21},"2028-12-30",{"name":735,"class":144},"Nanjing Sanhome Pharmaceutical, Co., Ltd."]