[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastro-esophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastro-esophageal-junction-adenocarcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100646247","phase-2-sac-tmt-combined-with-fruquintinib-as-second-line-treatment-in-patients-with-advanced-gastricgastroesophageal-junction-adenocarcinoma-100646247",false,"NCT07689292","Sac-TMT Combined With Fruquintinib as Second-Line Treatment in Patients With Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","SKB264-Fru-GA","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed metastatic or locally advanced adenocarcinoma of the gastric or gastroesophageal junction, unresectable;\n* Subjects who have failed first-line standard systemic therapy, or experienced disease progression or recurrence within 6 months after completion of adjuvant systemic therapy (HER2-positive subjects must have received prior anti-HER2 therapy);\n* Have at least one measurable lesion per RECIST v1.1, subjects with only cutaneous or bone lesions are not eligible for enrollment;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to study drug administration;\n* Estimated life expectancy \\> 12 weeks.\n* Adequate organ and bone marrow function (no transfusions, recombinant human thrombopoietin or colony-stimulating factor administered within 2 weeks prior to dosing), defined as follows:\n\n  1. Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹\u002FL; platelets (PLT) ≥ 80×10⁹\u002FL; hemoglobin ≥ 90 g\u002FL;\n  2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); for subjects with baseline liver metastases, ALT and AST ≤ 5 × ULN; albumin ≥ 30 g\u002FL; total bilirubin (TBIL) ≤ 1.5 × ULN;\n  3. Renal function: Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula);\n  4. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5 × ULN.\n* All acute toxicities from prior treatments have recovered to Grade 1 or lower (alopecia and vitiligo are excluded). Note: Subjects with any grade of prior endocrine adverse events may be enrolled if they only require maintenance hormone replacement therapy and are stable and asymptomatic at screening.\n* Females of childbearing potential and males with partners of childbearing potential must agree to use effective medical contraception from the time of informed consent signature through 6 months after the last dose of study drug;\n* The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with protocol-specified study visits and related procedures.\n\nExclusion Criteria:\n\n* Participants unable to receive oral administration due to dysphagia, intractable vomiting, or known drug malabsorption;\n* Participants with active gastric\u002Fduodenal ulcer, ulcerative colitis, intestinal obstruction, or other gastrointestinal disorders\u002Fconditions judged by the Investigator to carry a risk of gastrointestinal hemorrhage or perforation; or with a history of intestinal perforation or fistula within the preceding 6 months; or with unresolved intestinal perforation\u002Ffistula following prior surgical repair;\n* Participants with known meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For spinal cord compression, or active\u002Funtreated central nervous system (CNS) metastases. Participants with previously locally treated brain metastases may be enrolled if clinically stable for at least 4 weeks prior to dosing and not requiring corticosteroids or anticonvulsants for a minimum of 14 days before the first dose;\n* Participants diagnosed with another malignant tumor within 3 years prior to dosing, except malignancies cured by local therapy such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, carcinoma in situ of the cervix, etc.;\n* Participants with clinically significant cardiovascular disease, defined as:\n\n  1. Severe or uncontrolled cardiac disease or symptomatic cardiac conditions requiring treatment within 6 months prior to the first study dose, including congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, medically refractory unstable angina, severe arrhythmias requiring pharmacotherapy (excluding atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction;\n  2. Prior history of myocarditis or cardiomyopathy;\n  3. Baseline corrected QT (QTc) interval \\> 480 ms;\n* Participants with a history of arterial thromboembolism or deep vein thrombosis within the preceding 6 months;\n* Participants with documented or historical significant bleeding within 2 months prior to dosing, including melena, hematemesis, hemoptysis, ≥++ fecal occult blood. Subjects with 1+ fecal occult blood and underlying primary gastrointestinal lesions must complete gastroscopy prior to enrollment to rule out active bleeding or ulcers;\n* Participants with a history of stroke and\u002For transient ischemic attack (TIA) within 12 months prior to dosing;\n* Participants with severe and\u002For uncontrolled systemic diseases, such as unregulated metabolic disorders, active inflammatory bowel disease, or gastrointestinal perforation;\n* Participants with active hepatitis B \\[hepatitis B surface antigen (HBsAg)-positive, with HBV-DNA ≥1000 IU\u002FmL or above the lower limit of quantification (LLOQ), whichever is higher\\] or hepatitis C (hepatitis C antibody-positive with HCV-RNA above the LLOQ). Note: HBsAg-positive subjects must receive anti-HBV antiviral therapy throughout study treatment;\n* Participants with known poorly controlled human immunodeficiency virus (HIV) infection; subjects with active syphilis infection;\n* Participants with known active pulmonary tuberculosis;\n* Participants who have undergone major surgery (as defined by the Investigator) within 30 days prior to the first study dose, or are still in the postoperative recovery phase from prior surgery;\n* Participants with a history of severe hypersensitivity reactions to the study drug (including its excipients);\n* Participants with a history of non-infectious interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD\u002Fnon-infectious pneumonitis that cannot be ruled out via imaging at screening;\n* Participants with a history of allogeneic tissue\u002Forgan transplantation;\n* Participants previously treated with any of the following regimens (including adjuvant or neoadjuvant settings):\n\n  1. TROP2-targeted therapy;\n  2. Any therapy containing topoisomerase I inhibitors, including antibody-drug conjugates (ADCs);\n  3. Systemic therapy targeting the vascular endothelial growth factor receptor (VEGFR) signaling pathway;\n* Participants who received live vaccines within 30 days prior to dosing, or plan to receive live vaccines during the study period;\n* Participants requiring strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks before the first dose and throughout the study;\n* Participants who received chemotherapy, radiotherapy, immunotherapy, or biotherapy within 4 weeks before the first study dose;\n* Participants who received small-molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormonal therapy, systemic immune stimulants (including but not limited to interferon, IL-2), or proprietary Chinese medicines with approved anti-tumor indications within 2 weeks before the first study dose;\n* Participants with active infection requiring systemic anti-infective therapy within 2 weeks prior to dosing;\n* Participants with any disease requiring systemic corticosteroids (\\>10 mg prednisone equivalent daily) or other immunosuppressants within 14 days before the first study drug administration. Nasal, inhaled, topical, intra-articular corticosteroids, and corticosteroids administered for prophylaxis of infusion reactions are permitted;\n* Participants with documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal disorders with a history of impaired\u002Fdelayed corneal wound healing;\n* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test prior to the first dose;\n* Participants with urine protein ≥2+ and 24-hour urinary protein \\>1 g; or with uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);\n* Any other condition that, in the Investigator's judgment, renders the subject unsuitable for participation in this study.","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.",[27,28,29],"Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma","Gastro-esophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-07-07",{"date":33,"type":34},"2026-07-09","ACTUAL",{"date":36,"type":21},"2026-07-31",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100578259","phase-2-adebrelimab-combined-with-nab-paclitaxel-oxaliplatin-and-tegafur-aos-for-perioperative-treatment-of-locally-advanced-resectable-gcgej-100578259","NCT06808971","Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC\u002FGEJ","A Phase II Clinical Trial of Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur Gimeracil Oteracil Potassium Capsule for Perioperative Treatment of Locally Advanced Resectable Gastric\u002FGastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study and sign informed consent forms;\n2. 18-75 years old;\n3. Patients whose tumor has been pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and has not received any type of antitumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);\n4. Confirmed TNM staging by CT or MRI as resectable cT3-4N+M0;\n5. ECOG score is 0-1;\n6. Patients who are able to swallow pills and capsules normally;\n7. Patients whose expected survival period is longer than 12 weeks;\n8. The function of important organs meets the following requirements:\n\nA. Absolute number of neutrophils (ANC) ≥1.5×10\\^9\u002FL B. Platelet number ≥90×10\\^9\u002FL; C. Hemoglobin ≥90g\u002FL; D.Total bilirubin ≤1.5×ULN; ALT, AST and\u002For AKP≤2.5×ULN; E. Serum creatinine ≤1.5×ULN or creatinine clearance rate \\>60mL\u002Fmin (Cockcroft-Gault); F. Activated partial thromboplastin time (APTT) and international standardization ratio (INR) ≤1.5×ULN (for anticoagulation treatments using stable doses such as low-molecular heparin or warfarin and INR can be screened within the expected treatment range of anticoagulants); 9. Female patients with fertility must undergo a blood pregnancy test within 72 hours before the first administration of the drug and the result is negative. During the study period and at least 6 months after the last dose of the study drug, a medically approved contraceptive measure (such as intrauterine birth control device, contraceptive pill or condom) must be used; for men, it should be surgery, sterilization, or agree to use effective contraception during the study period and within 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Patients who are known to have peritoneal metastasis or positive peritoneal lavage cytology (CY1P0) or have distant metastasis;\n2. Patients whose tumor can not be resected by surgery for tumor reasons or comorbidity or patients who refuse to undergo surgery;\n3. Patients who have other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical in situ and breast cancer in situ;\n4. The toxicity of previous anti-tumor treatment has not recovered to CTCAE≤grade one (NCI CTCAEv5.0), except for hair loss (any level allowed) and peripheral neuropathy (need to be ≤grade two );\n5. Active bleeding;\n6. Patients who had gastrointestinal perforation, abdominal abscess or recent intestinal obstruction or imaging and clinical symptoms with intestinal obstruction in the past 3 months;\n7. Uncontrollable hypertension, symptomatic cardiac insufficiency, and severe heart disease within 6 months, including but not limited to:\n\n(1) Acute coronary syndrome; (2) Arrhythmias that require drug treatment or have clinical significance, or do not interrupt the use of drugs that may lead to QT prolongation during the research period; (3) Acute myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by the researchers to be unsuitable for participating in this trial.\n\n8\\. Patients who have active ulcers, unhealed wounds or fractures; 9. Patients who need antimicrobial treatment in the stage of active infection; 10. Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥500IU\u002Fml; hepatitis C reference: HCV antibody positive and HCV virus copy number \\> normal value upper limit); 11. Patients with congenital or acquired immunodeficiency; 12. Patients who are planning to receive or have previously received organ or allogeneic bone marrow transplantation; 13. At present, patients who are accompanied by interstitial pneumonia or interstitial lung disease, or who have a previous history of interstitial pneumonia or interstitial lung disease that require hormone treatment, or other patients who may interfere with the judgment and treatment of immune-related pulmonary toxicity, fibrosis, organic pneumonia (such as occlusion bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or screening CT showing active pneumonia or severe pulmonary function impairment; active pulmonary tuberculosis; 14. Patients with any active autoimmune diseases or a history of autoimmune diseases with the possibility of recurrence \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients who can only be controlled by hormone replacement therapy can be included in the group)\\]; patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, hair loss, patients with type I diabetes that can be controlled by insulin treatment or have a history of asthma, but who have been completely relieved in childhood and do not require any intervention can be included in the group; asthma patients who need the intervention of bronchodilators cannot be included in the group; 15. Patients who are using immunosuppressive drugs or systemic corticosteroid treatment within 7 days before joining in the group to achieve the purpose of immunosuppression (\\>10mg\u002Fday of prednisone or other equivalent drugs); 16. Patients who have received live attenuated vaccine within 28 days before joining in the group, or need to inject such vaccines during treatment or within 60 days after the last dose; 17. Oral or intravenous antibiotics or intravenously within 4 weeks before joining the group (except for preventive antibiotics administered intravenously for no more than 48 hours); 18. Known allergies to any study drugs or excipients; 19. Participated in clinical research of other drugs 4 weeks before joining in the group; 20. Lactating women; 21. According to the researcher's judgment, the patient has other factors that may affect the research results or cause the forced termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness that need combined treatment, and serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of patients);","75 Years",{"count":51,"type":21},61,[24],"This study is a single-arm, prospective, phase II clinical trial. The patients are diagnosed with resectable locally advanced (cT3-4N+M0) gastric adenocarcinoma and esophageal gastric adenocarcinoma that had not been treated before.\n\nAfter signing the informed consent form, patients will be screened for the study treatment of Adebrelimab combined with AOS. After 2 cycles of treatment, MDT assessments before surgery will be carried out. Patients with no disease progression will receive one more cycle of treatment before surgery. For patients who have undergone radical surgery, they will continue to receive 3 cycles of the immunochemotherapy after the operation (a total of 6 cycles of combined treatment before and after surgery), followed by Adebrelimab single treatment for up to a year (16 cycles).\n\nPatients whose disease progressed that can not be surgically removed after preoperative treatment will be treated by the oncology physicians according to clinical routines.",[27,29],"RECRUITING","2026-04-19",{"date":58,"type":34},"2026-04-23",{"date":60,"type":34},"2025-02-28",{"date":62,"type":21},"2027-12-31",{"name":64,"class":41},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",1]