drugset / Trial / NCT06761846

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

NCT06761846

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-17
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule
Subject Gimeracil Small molecule
Subject Oxaliplatin Small molecule
Subject S-1 Small molecule
Subject Sintilimab Monoclonal antibody
Subject oteracil Small molecule