Multicenter phase 3 trial of addition of sorafenib to transarterial chemoembolization for recurrent intermediate-stage hepatocellular carcinoma

Transarterial chemoembolization (TACE) is commonly used to treat patients with recurrent intermediate-stage hepatocellular carcinoma (HCC) with microvascular invasion (MVI). The survival benefits with this therapy are unsatisfactory. A phase 3 trial at 5 centers in China compared sorafenib plus TACE (SOR-TACE) versus TACE alone after R0 hepatectomy for recurrent intermediate-stage HCC with MVI. In this randomized controlled trial of 162 patients, the SOR-TACE group compared with the TACE group had a significantly longer median overall survival (22.2 months versus 15.1 months) and progression-free survival (16.2 months versus 11.8 months). The SOR-TACE safety profile was acceptable compared with TACE alone. The authors conclude that SOR-TACE for patients with recurrent intermediate-stage HCC with MVI improved survival compared with TACE alone (visual abstract).