NCT04709380

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

Phase III Randomized Clinical Trial of Radiotherapy Plus Toripalimab Versus Sorafenib in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an single-center, open, randomized study, which is going to enroll patients filtered to meet the standard of advanced hepatocellular carcinoma, in a 2: 1-proportional randomly assigned to the test group and control group. Patients in the experimental group will be given local vein tumor thrombus/hepatic vein tumor thrombus +/- intrahepatic large lesions with hypofractionated intensity-modulated radiotherapy (tumor area dose 40-60Gy/10-20f), concurrent with and followed by 240mg Q3W of toripalimab within 1 week of radiotherapy started. Patients in the control group will be treated with sorafenib (400mg, twice a day).

Conditions

• Radiotherapy
• Toripalimab
• Sorafenib
• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	Radiotherapy plus Toripalimab	Intensity modulated radiotherapy has shown important role in the treatment of hepatocellular carcinoma (HCC), especially for advanced disease with portal vein tumor thrombosis (PVTT), or hepatic vein tumor thrombosis. Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).
DRUG	Sorafenib	Sorafenib is a multi-targeted oral drug for the treatment of cancer.Treatment of inoperable advanced renal cell carcinoma ,inoperable or distant metastatic primary hepatocellular carcinoma and so on.

Timeline

• Start date: 2021-03-02
• Primary completion: 2024-12-27
• Completion: 2025-02-05
• First posted: 2021-01-14
• Last updated: 2025-02-26

Locations

1 site across 1 country: China