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