drugset / Trial / NCT05143099

Phase II Study of Tislelizumab Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory mCRC

NCT05143099 ↗

Phase 2 Unknown 35 enrolled Shanghai Zhongshan Hospital
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

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody — —
Subject Irinotecan Small molecule — —
Subject Tislelizumab Monoclonal antibody — —

Indications