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Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): A phase 3 randomised controlled trial

The Lancet: Gastroenterology & Hepatology May 12, 2019

Merle P, et al. - Among patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed, researchers evaluated the intravenous perfusion of doxorubicin-loaded nanoparticles. For this multicentre, open-label, randomised, controlled phase 3 trial, hepatocellular carcinoma patients with one or more previous systemic therapies, including sorafenib, were randomly assigned to receive 30 mg/m2 doxorubicin-loaded nanoparticles (30 mg/m2 group), 20 mg/m2 doxorubicin-loaded nanoparticles (20 mg/m2 group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region. The authors concluded that doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous treatment with sorafenib had failed. Neutropenia, asthenia, and thrombocytopenia were the most common drug-related grade 3 or 4 treatment-emergent adverse events.
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