drugset / Trial / NCT07559760
New Second-Line Combo Therapy for MSS Metastatic Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, single-arm study designed to evaluate the efficacy and safety of second-line treatment in patients with advanced colorectal cancer (those who have progressed on or are intolerant to first-line oxaliplatin-based regimens with or without targeted therapy) receiving Levofolinic Acid + 5-FU continuous infusion combined with irinotecan hydrochloride liposome ± cetuximab/bevacizumab. Approximately 30 patients will be enrolled.
Timeline
- Start
- 2025-11-01
- Primary completion
- 2027-05-31
- Completion
- 2029-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Levoleucovorin | Unknown | 200 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |