Adjuvant transarterial chemoembolization with sorafenib for patients with hepatocellular carcinoma with portal vein tumor thrombus after surgery: A phase III, multicenter, randomized, controlled trial.

• DOI: 10.1200/jco.2023.41.4_suppl.493
• Publication Date: 2023-01-24T21:05:07Z
• Authors: Ming Kuang; Zhenwei Peng; Wenzhe Fan; Zelong Liu; Han Xiao; Jianfei Tu; Rong Tang; Zhen Huang; Yu Cheng; Fuliang Li; Mingjian Lu; Jiaping Li
• Keywords: Clinical endpoint

493 Background: To compare the efficacy and safety of sorafenib plus transarterial chemoembolization (SOR-TACE) versus alone as postoperative adjuvant therapy for hepatocellular carcinoma (HCC) patients with portal vein thrombus (PVTT). Methods: This was a phase III, multicenter, randomized, control clinical trial. Eligible HCC PVTT were included randomly assigned (1:1) to receive SOR-TACE or therapy. Sorafenib treatment started within 3 days after randomization, an initial dose 400mg twice day. In group, TACE performed one day administration sorafenib. The primary endpoint recurrence-free survival (RFS). Results: From October 2019 March 2022, total 158 from China enrolled randomized. After median follow-up duration 28.4 months, RFS significantly longer in group (16.8 vs. 12.6 months; hazard ratio, 0.57; P = 0.002). overall (OS) also than (30.4 22.5 0.017). Multivariable analysis indicated independent risk factor both OS. did not show additional toxicity compared group. Conclusions: combination resulted OS well tolerated. Clinical trial information: NCT04143191 .