Multicenter phase 3 study of adjuvant hepatic artery FOLFOX infusion for hepatocellular carcinoma with microvascular invasion

There is no standard adjuvant treatment for hepatocellular carcinoma (HCC) with microvascular invasion (MVI). A multicenter phase 3 study in China evaluated postoperative hepatic artery infusion chemotherapy (HAIC) with FOLFOX for HCC with MVI. Patients were randomized 1:1 to FOLFOX-HAIC (‘treatment group’) or routine follow-up (‘control group’). In the ITT population, the median DFS was 20.3 months in the treatment group versus 10.0 months in the control group (panel A; HR 0.59; p=0.001). Panel B shows the OS in the ITT population, panel C shows the DFS in the PP population, and panel D shows the OS in the PP population. Majority (83.3%) of the adverse events were grade 0-1. There were no grade 5 AEs. The authors conclude that postoperative FOLFOX HAIC significantly improved DFS with acceptable toxicity in HCC patients with MVI.