drugset / Trial / NCT04135690

HAIC Plus Toripalimab vs. HAIC Plus Sorafenib for HCC With PVTT: a Non-comparative, Prospective, Randomized Trial

NCT04135690 ↗

Phase 2 Unknown 60 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.

Timeline

Start
2019-10-20
Primary completion
2023-12-20
Completion
2023-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sorafenib Small molecule 400 mg Oral
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background Atezolizumab Monoclonal antibody — —
Background Bevacizumab Monoclonal antibody — —
Background Camrelizumab Monoclonal antibody — —
Background Rivoceranib Small molecule — —
Background Sintilimab Monoclonal antibody — —