drugset / Trial / NCT05143099
Phase II Study of Tislelizumab Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory mCRC
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment in the past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 33 patients were planned to be treated with tislelizumab combined with cetuximab + irinotecan every 2 weeks. The enrollment time is expected to be 12 months and the follow-up is 24 months.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2022-12-12
- Completion
- 2024-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | — | — |
| Subject | Irinotecan | Small molecule | — | — |
| Subject | Tislelizumab | Monoclonal antibody | — | — |