NCT06761846

Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ

A Phase II Study of Sintilimab Combined With Chemotherapy as Postoperative Adjuvant Treatment for Phase III Gastric Adenocarcinoma (GC) and The Adenocarcinoma of Esophagogastric Junction (GEJ)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection. After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX) , in which the combined chemotherapy is up to 8 cycles, and the total course of treatment was 16 cycles. The following-up of subjects includes adverse events、disease status、living conditions and the quality of life.

Detailed description

This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection that meets the criteria for group entry and does not meet the exclusion criteria. After signing the informed consent, the subjects entered the trial group to receive adjuvant treatment with Sintilimab combined with chemotherapy (SOX or XELOX ), in which SOX or XELOX chemotherapy was up to 8 cycles, and the total course of treatment was 16 cycles. The efficacy is evaluated every 4 cycles during the study treatment. The frequency of follow-up after treatment is defined as: once every 3 months within 2 years after surgery, every 6 months for 2 to 5 years, and once a year after 5 years. The follow-up interval can be adjusted according to the clinical need. Safety follow-up is from the beginning of the first treatment to 30 days after the last medication.

Conditions

• Gastric Adenocarcinoma
• Esophagogastric Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab plus Chemotherapy	chemotherapy includes SOX and XELOX

Timeline

• Start date: 2025-01-17
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-01-07
• Last updated: 2026-01-22

Locations

1 site across 1 country: China