drugset / Trial / NCT06858969
Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer
Phase 2
Not yet recruiting
130 enrolled
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination regimen, and (3) obtain preliminary efficacy data including objective response rate (ORR) and progression-free survival (PFS).
Timeline
- Start
- 2025-04-09
- Primary completion
- 2026-01-08
- Completion
- 2028-01-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | — | Oral |
| Background | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |