NCT07492615

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

Sintilimab Combined With SOX Versus SOX as Adjuvant Therapy for Patients With Stage pIIIC or dMMR/MSI-H Stage pIIIA/IIIB Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Randomized Controlled Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, randomized controlled phase II clinical study.The primary endpoint was 3-year disease-free survival (3yr-DFS). The secondary endpoints were disease-free survival (DFS), overall survival (OS), and safety. The study used RECIST v1.1 for imaging assessment. Tumor imaging evaluations were conducted every 12 weeks (±7 days) until disease recurrence, death, or up to 24 months, and then every 24 weeks (±7 days) thereafter. The same imaging technique should be used for the same subject throughout the study period. Safety follow-up was from the first treatment to 30 days after the last treatment.

Conditions

• Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	200 mg, administered intravenously, d1, every 3 weeks
DRUG	S-1 & Oxaliplatin	S-1:Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks. Oxaliplatin: 130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.

Timeline

• Start date: 2026-01-29
• Primary completion: 2029-02-20
• Completion: 2033-02-20
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China