Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC

Summary

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.

Timeline

Start

2019-09-15

Primary completion

2021-09-15

Completion

2023-09-15

Outcome

Met primary endpoint

paper recurrence-free survival was significantly longer in the transarterial chemoembolization with sorafenib group PMID 38568599 ↗

paper hazard ratio [HR], 0.57; 95% CI, 0.39-0.83; P = .002 PMID 38568599 ↗

Publications

• Peng Z, Fan W, Liu Z, Xiao H, Wu J, Tang R, Tu J, Qiao L, Huang F, Xie W, Zhuang W, Guo W, Li S, Hua Y, Shen S, He Q, Li D, Li J, Kuang M. Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus: A Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):616-624. doi: 10.1001/jamasurg.2024.0506.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	400 mg	Oral

Indications