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

NCT07492615 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xiaowen Liu · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492615 on ClinicalTrials.gov