[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibi363--chemotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibi363--chemotherapy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100617977","phase-2-perioprative-study-of-ibi363-in-patients-with-mhc-ii-negative-locally-advanced-gastric-cancer-100617977",false,"NCT07325630","Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer","IBI363 Combined Chemotherapy for Perioperative Treatment of MHC-II-Negative Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Single-Center, Single-Arm Phase II Clinical Study","Key Inclusion Criteria:\n\n1. Patients voluntarily enrolled in this study and signed informed consent forms;\n2. Age 18-75 years;\n3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;\n4. MHC-II negative, with \\\u003C5% tumour cells displaying staining \\\u003C2+ (grade 2 or stronger);\n5. Clinically staged as cT3-4aN+M0 gastric or gastroesophageal junction adenocarcinoma confirmed by CT and\u002For laparoscopy (per AJCC 8th Edition staging);\n6. No prior antineoplastic therapy for current disease (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy);\n7. Scheduled for surgical intervention following completion of neoadjuvant therapy;\n8. Able to swallow tablets orally;\n9. ECOG performance status 0-1;\n10. Expected survival ≥6 months.\n\nKey Exclusion Criteria:\n\n1. Pregnant or lactating women, or women planning to become pregnant within 6 months prior to, during, or after the last dose of the investigational medicinal product.\n2. Known signs of active bleeding from a lesion.\n3. Patients with known dMMR\u002FMSI-H status.\n4. Oesophageal or pyloric near-obstruction affecting the subject's ability to eat or gastric emptying, or difficulty swallowing tablets.\n5. Subjects with unresolved Grade \\>1 toxicity related to any prior antineoplastic therapy (excluding persistent Grade 2 alopecia, anaemia, peripheral neuropathy, electrolyte abnormalities correctable with treatment, or endocrine abnormalities controlled and stable with hormone replacement therapy).\n6. Known dihydropyrimidine dehydrogenase (DPD) deficiency (or prior fluorouracil-containing therapy resulting in Grade 3 or higher mucositis).\n7. Known hypersensitivity to any monoclonal antibody or component of the chemotherapy agents (capecitabine, oxaliplatin) (resulting in Grade 3 or higher hypersensitivity reaction).\n8. History of epileptic seizures, active, newly diagnosed, or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases.\n9. Clinically significant cardiovascular or cerebrovascular disease.","ALL","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase 2 study designed to evaluate the safety and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) or S-1 and oxaliplatin (SOX) in perioprative treatment of locally advanced MHC-II-negative gastric and gastroesophageal junction adenocarcinoma.",[27],"IBI363 + Chemotherapy","RECRUITING","2025-12-24",{"date":31,"type":32},"2026-01-08","ACTUAL",{"date":34,"type":32},"2025-11-03",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Zhejiang Cancer Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100563025","phase-1-study-of-ibi363-in-patients-with-advanced-first-line-gastric-cancer-100563025","NCT06610799","Study of IBI363 in Patients with Advanced First-line Gastric Cancer","Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years and ≤75 years.\n2. Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.\n3. Subjects with at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n5. Expected survival time ≥ 3 months.\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.\n2. Active uncontrolled bleeding or a known bleeding diathesis.\n3. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.",{"count":49,"type":21},40,[51],"PHASE1","This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.",[27],"2024-11-18",{"date":56,"type":32},"2024-11-20",{"date":58,"type":32},"2024-10-15",{"date":60,"type":21},"2026-12-31",{"name":62,"class":39},"Xiangdong Cheng"]