drugset / Trial / NCT07622550
A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance
NaSingle-groupOpen-labelTreatment
Summary
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS/BRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.
Timeline
- Start
- 2026-06-15
- Primary completion
- 2027-12-15
- Completion
- 2028-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Fruquintinib | Small molecule | 3 mg | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 4.5 mg/kg | Intravenous |