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Sorafenib

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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.

Patients in the control group will be treated with sorafenib (400mg, twice a day).

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).

Radiotherapy plus Toripalimab

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.

Bo Chen, MD

Huiying Zeng, MD

Liming Wang, MD

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

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).

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

Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death.

Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Overall Survival (OS) was defined as the duration from the date of patient recruited to the date of death with any reason.

Adverse events was evaluated during received protocol therapy according to CTCAE 4.03.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III RCT of Radiotherapy Plus Toripalimab Versus Sorafenib in Advanced Hepatocellular Carcinoma With PVTT	NCT04709380	Radiotherapy Toripalimab Sorafenib Advanced Hepato...	Radiotherapy pl... Sorafenib	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase III RCT of Radiotherapy Plus Toripalimab Versus Sorafenib in Advanced Hepatocellular Carcinoma With PVTT	NCT04709380	Radiotherapy Toripalimab Sorafenib Advanced Hepato...	Radiotherapy pl... Sorafenib	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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