drugset / Trial / NCT05171660
Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |