NCT07483567

IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

A Randomized, Open-label, Multicenter Phase II Clinical Study to Explore the Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With IBI343 in Combination With Sintilimab and SOX Regimen.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.

Conditions

• CLDN18.2 Positive
• Primary Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	IBI343,sintilimab,oxaliplatin,S-1	IBI343,sintilimab,oxaliplatin,S-1
DRUG	sintilimab,oxaliplatin,S-1	sintilimab,oxaliplatin,S-1

Timeline

• Start date: 2026-03-30
• Primary completion: 2030-06-30
• Completion: 2031-06-30
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China