This is the report of the RELIVE phase 3 trial evaluating the intravenous perfusion of doxorubicin-loaded nanoparticles in patients with advanced HCC who have previously received sorafenib. 297 patients were randomly assigned, 133 to 30 mg/m2 doxorubicin-loaded nanoparticles, 130 to 20 mg/m2 doxorubicin-loaded nanoparticles, 134 to standard of care (control group). At a median follow-up of 22·7 months (IQR 11.2-34.9), median overall survival was not improved in the pooled doxorubicin-loaded nanoparticles group (9·1 months [95%CI 8·1–10·4]) compared to the control group (9·0 months [95%CI 7·1–11·8]) (HR 1·00 [95%CI 0·78–1·28], two-sided p=0·99).
(Merle P et al. – Lancet Gastroenterology & Hepatology, 3 April 2019)