drugset
drugset / Trial / NCT07492615

A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma

NCT07492615 ↗

Phase 2 Recruiting 276 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.

Timeline

Start
2026-01-29
Primary completion
2029-02-20
Completion
2033-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background S-1 Small molecule 40 mg Oral
Background S-1 Small molecule 60 mg Oral

Indications

gastroesophageal adenocarcinoma