drugset / Trial / NCT07374250

Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma

NCT07374250

Phase 2 Not yet recruiting 154 enrolled Sichuan University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (SOX) is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen. Primary Objective: To determine whether perioperative ivonescimab plus SOX improves the pathological complete response (pCR) rate compared with SOX alone in patients with locally advanced gastric or GEJ adenocarcinoma. Study Design: Participants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting. Participation Details: Participants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 months. They will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring. Participants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.

Timeline

Start
2026-02-01
Primary completion
2027-12-31
Completion
2027-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivonescimab Monoclonal antibody 20 mg/kg
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background S-1 Small molecule 80 mg Oral
Background S-1 Small molecule 100 mg Oral
Background S-1 Small molecule 120 mg Oral

Indications