drugset / Trial / NCT05969899
Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The goal of this prospective clinical trial is to evaluate efficacy and safety of irinotecan liposomes for first-line treatment of advanced colorectal cancer. The primary endpoint is Objective response rate (ORR) per RECIST 1.1. The secondary endpoints are overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and safety based on NCI-CTCAE 5.0
Timeline
- Start
- 2023-07-10
- Primary completion
- 2025-07-10
- Completion
- 2027-02-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan liposome | Unknown | 60 mg/m2 | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | FU | Unknown | 2400 mg/m2 | Intravenous |
| Background | LV | Unknown | 400 mg/m2 | Intravenous |