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/Gastroesophageal Junction Adenocarcinoma: A Single-Center, Single-Arm Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• IBI363 + Chemotherapy

Interventions

Type	Name	Description
DRUG	IBI363 + chemotherapy	IBI363 Q3W +XELOX Q3W (Oxaliplatin 130 mg/m2, IV, Q3W, Capecitabine ,1000mg/ m2, PO, Bid, d1-14, Q3W) or IBI363 Q3W +SOX (Oxaliplatin 130 mg/m2, IV, Q3W, S-1, 40-60mg,PO, Bid, d1-14，Q3W )

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-05-30
• Completion: 2027-12-31
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: China