RecruitingPhase 2NCT07492615

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


Sponsor

Fudan University

Enrollment

276 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called S-1 & Oxaliplatin and a drug called Sintilimab for people with gastric cancer or gastroesophageal junction adenocarcinoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab

200 mg, administered intravenously, d1, every 3 weeks

DRUGS-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.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07492615


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