drugset / Trial / NCT05877001

The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases

NCT05877001 ↗

Phase 2 Unknown 20 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelTreatment

Summary

Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases. NCCN guidelines and several expert consensus recommend that regional hepatic arterial infusion chemotherapy can be considered as a "rescue treatment" for patients with colorectal cancer liver metastases who fail to receive first-line or second-line systemic chemotherapy, which can significantly prolong the overall survival of patients.

Timeline

Start
2023-05-30
Primary completion
2024-07-30
Completion
2025-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Regorafenib Small molecule 80 mg —
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous