This is the report of a randomized, open-label clinical trial investigating the efficacy and safety of sorafenib plus HAIC (SoraHAIC) compared to sorafenib in patients with HCC and PVT. This trial was conducted at 5 hospitals in China, 818 patients were enrolled, and 247 patients with HCC and PVT were randomized 1:1 to receive SoraHAIC or sorafenib. Median overall survival was 13.37 months (95%CI 10.27-16.46) in the SoraHAIC group vs 7.13 months (95%CI 6.28-7.98) in the sorafenib group (HR 0.35; 95%CI 0.26-0.48; p<0.001); the SoraHAIC group showed also a higher response rate and a longer progression-free survival. Grade 3/4 adverse events observed more frequently in the SoraHAIC group included neutropenia (9.68% vs 2.48%), thrombocytopenia (12.9% vs 6 4.96%), and vomiting (6.45% vs 0.83%).
(He M et al. – JAMA Oncology, 9 May 2019)