drugset / Trial / NCT06225622
Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
Dose escalation clinical trial: To explore the dose limiting toxicity (DLT) of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab in first-line treatment of patients with advanced metastatic colorectal cancer, and to estimate the maximum tolerated dose (MTD) of combined administration. Expansion clinical trial: To evaluate the safety and efficacy of irinotecan liposome injection combined with oxaliplatin +5-FU/LV+ bevacizumab or cetuximab in first-line treatment of patients with advanced metastatic colorectal cancer. Exploratory analysis of ctDNA changes and genetic mutations in patients at baseline.
Timeline
- Start
- 2024-03-11
- Primary completion
- 2026-01-01
- Completion
- 2026-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 80 mg/m2 | Intravenous |
| Background | LV | Unknown | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |