drugset / Trial / NCT05171660

Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer

NCT05171660

Phase 3 Active not recruiting 446 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University
RandomizedParallel-groupOpen-labelTreatment

Summary

Sintilimab (R\&D code: IBI308) is a recombinant human-derived IgG4 type PD-1 monoclonal antibody. PD-1 inhibitor combined with chemotherapy has synergistic effect to further enhance anti-tumor immunity. This study is a phase III clinical study of a three-week regimen of sintilimab combined with the XELOX+ bevacizumab for RAS-mutant metastatic colorectal cancer patients who had not received any treatment before. The purpose of this study is to explore the efficacy of sintilimab combined with XELOX + bevacizumab as first line therapy.

Timeline

Start
2022-02-08
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Background Capecitabine Small molecule 1 g Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications