drugset / Trial / NCT05555901
The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multi-center, randomized study evaluating the efficacy and safety of fruquintinib combined with chemotherapy vs bevacizumab combined with chemotherapy as second-line treatment in patients with metastatic colorectal cancer. Patients will receive fruquintinib+ FOLFIRI or bevacizumab+FOLFIRI as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive fruquintinib + capecitabine or bevacizumab+ capecitabine as maintenance treatment. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.
Timeline
- Start
- 2023-06-18
- Primary completion
- 2025-09
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | — |
| Background | Fruquintinib | Small molecule | 4 mg | Oral |
| Comparator | Bevacizumab | Monoclonal antibody | 400 mg/m2 | — |
| Comparator | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Background | Fruquintinib | Small molecule | 400 mg/m2 | — |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | — |