[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-unresectable-or-metastatic-gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-unresectable-or-metastatic-gastric-cancer":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100635061","a-long-term-follow-up-study-of-subjects-enrolled-in-clinical-trials-of-cadonilimab-ak104-100635061",false,"NCT07547787","A Long-term Follow-up Study of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)","An Extension Study for Collecting Long-term Follow-up Data of Subjects Enrolled in Clinical Trials of Cadonilimab (AK104)","Inclusion Criteria:\n\n1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.\n2. Subjects have received prior systemic therapy in sponsor-initiated clinical trials of cadonilimab (AK104), and this extension study is conducted after the completion of the original trial.\n3. Agree to proceed with the extended follow-up procedures.\n4. This is an observational and non-interventional clinical study, in which subjects are allowed to participate in other clinical studies at the same time.\n\nExclusion Criteria:\n\n* None","ALL",{"count":18,"type":19},610,"ESTIMATED","5 Years","OBSERVATIONAL","This is an observational and non-interventional clinical study that only collects long-term follow-up data of the subjects. As the world's first approved PD-1\u002FCTLA-4 bispecific antibody for marketing, Cadonilimab may confer long-term survival benefits.",[24],"Locally Advanced Unresectable or Metastatic Gastric Cancer","RECRUITING","2026-04-17",{"date":28,"type":29},"2026-04-23","ACTUAL",{"date":31,"type":29},"2024-12-26",{"date":33,"type":19},"2040-12-31",{"name":35,"class":36},"Akeso","INDUSTRY",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":37},"100529689","phase-3-m108-plus-capox-versus-placebo-plus-capox-as-first-line-treatment-for-claudin-cldn-182-positive-her2-negative-pd-l1-cps5-locally-advanced-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-gej-adenocarcinoma-100529689","NCT06177041","M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS\u003C5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.","A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS\u003C5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.","Inclusion Criteria:\n\n1. Written informed consent\n2. Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric\u002FGEJ adenocarcinoma with no treatment previously. For patients with neoadjuvant\u002Fadjuant chemotherapy in the past, duration of last therapy to recurrence should be more than 6 months\n3. At least 1 measurable site of the disease according to RECIST 1.1 criteria.\n4. Positive CDLN 18.2 expression\n5. Negative HER2 expression, PD-L1 CPS\\\u003C5\n6. ECOG performance status (PS) 0-1\n7. Life expectancy \\> 3 months\n8. Age ≥ 18 years and ≤75 years\n9. Adequate haematological\u002F coagulation\u002F hepatic\u002F renal function\n10. Men and women of childbearing age should agree to use effective contraception from the time they sign their informed consent until 3 months after the last dosing. Female subjects of childbearing age must have a negative blood beta-HCG test within 72 hours prior to first dosing.\n\nExclusion Criteria:\n\n1. Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastases and the patient recovered from acute toxicity was allowed).\n2. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.\n3. Previous major operation within 4 weeks prior to the start of study treatment.\n4. Have a prior severe allergic reaction or intolerance to known components of M108 monoclonal antibodies or other monoclonal antibodies (including humanized or chimeric antibodies); Allergic or intolerant to any component of capecitabine, oxaliplatin, etc.\n5. Subject who has been treated with CLDN18.2 monoclonal\u002Fbispecific antibodies, CLDN18.2 CAR-T, CLDN18.2 ADC and any therapies that target CLDN18.2.\n6. Subject who is in pregnant or in lactation period.\n7. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study.","18 Years","75 Years",{"count":48,"type":19},486,"INTERVENTIONAL",[51],"PHASE3","Gastric\u002FGEJ adenocarcinoma, which is one of the major leading causes of cancer-related deaths worldwide, is a global challenge to human health. However, standard chemotherapy has limited efficacy in advanced gastric cancer, and there is an urgent need to explore and develop new therapeutic targets and combination therapy modalities. The main purpose of this study is to explore the efficacy of M108 monoclonal antibody plus capecitabine and oxaliplatin (CAPOX) versus placebo plus CAPOX as first-line treatment measured by progression free survival (PFS). This study will also evaluate safety, tolerability, pharmacokinetics and the immunogenicity profile of M108 monoclonal antibody, as well as its effects on quality of life.",[24,54],"Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","2024-02-25",{"date":57,"type":29},"2024-02-28",{"date":59,"type":29},"2023-12-25",{"date":61,"type":19},"2027-04-11",{"name":63,"class":36},"FutureGen Biopharmaceutical (Beijing) Co., Ltd"]