drugset / Trial / NCT06992648
Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to demonstrate the non-inferiority of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC. Other secondary objectives are to compare the safety and tolerance, and the impact on QoL of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in patients with refractory mCRC.
Timeline
- Start
- 2025-04-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Regorafenib | Small molecule | 120 mg | Oral |
| Comparator | Tipiracil | Small molecule | 30 mg/m2 | Oral |
| Comparator | Tipiracil | Small molecule | 35 mg/m2 | Oral |
| Comparator | Trifluridine | Small molecule | 30 mg/m2 | Oral |
| Comparator | Trifluridine | Small molecule | 35 mg/m2 | Oral |