drugset / Trial / NCT05278351
Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, controlled, phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab and irinotecan（group A） compared to third-line regimens selected by researchers（group B） in the treatment of Ras wild-type recurrent and refractory metastatic colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment inthe past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 87 patients will be randomly assigned to group A and group B according to 2:1. The enrollment time is expected to be 12 months and the follow-up is expected to be 24 months.
Timeline
- Start
- 2022-07-13
- Primary completion
- 2024-04-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Regorafenib | Small molecule | 160 mg | — |
| Comparator | TAS-102 | Small molecule | 35 mg/m2 | — |
| Comparator | Third-line regimens | Unknown | 5 mg | — |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |