drugset
drugset / Trial / NCT04709380

Phase III RCT of Radiotherapy Plus Toripalimab Versus Sorafenib in Advanced Hepatocellular Carcinoma With PVTT

NCT04709380 ↗

Phase 3 Terminated 36 enrolled Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

To explore the efficacy of radiotherapy plus toripalimab Versus standard treatment of sorafenib in advanced hepatocellular carcinoma with Portal Vein/Hepatic vein Tumor Thrombosis.

Timeline

Start
2021-03-02
Primary completion
2024-12-27
Completion
2025-02-05

Outcome

Outcome not reported

Stopped: “IDMC recommended to terminate the study since Interim analysis showed that the experimental group had significant superiority over the control group in TTP and OS (p\<0.001), meeting the predefined interim analysis endpoints in the study protocol.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sorafenib Small molecule 400 mg Oral
Subject Toripalimab Monoclonal antibody 240 mg —

Indications

hepatocellular carcinoma