drugset / Trial / NCT06979908
A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). A total of 46 patients are planned to be enrolled, with the primary endpoint being median progression-free survival (mPFS). Secondary endpoints include median overall survival (mOS), objective response rate (ORR), and safety.
Timeline
- Start
- 2025-01-22
- Primary completion
- 2026-07-22
- Completion
- 2027-01-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fruquintinib | Small molecule | 5 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tucidinostat | Small molecule | 30 mg | Oral |