Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma
Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study
Sponsor: Sichuan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Total pathological complete response (pCR; ypT0) assessed by investigators, defined as the complete absence of tumor cells in the primary tumor on pathological examination.
Time frame: Perioperative
Secondary Endpoints
Event-free survival (EFS)
major pathologic response
R0 resection
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years. 2. Histologically confirmed gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI). 5. Considered eligible for curative resection. 6. No prior antitumor therapy for the current disease. 7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria. 8. Expected survival of ≥6 months. Exclusion Criteria: 1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor. 2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled. 3. Tumor lesions with a bleeding…
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