Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial
Hepatocellular carcinoma (HCC) is the third cause of death for cancer in the world with an
increasing incidence. No systemic therapy has proven effective in patients with advanced HCC
until 2007, when results of the SHARP trial were presented. In this trial, the orally active
multi-kinase inhibitor sorafenib (800 mg/day) significantly prolonged survival compared with
placebo in patients with advanced HCC and good liver function (Child A). The same authors
concluded that the effect of the drug in the population of patients with more impaired liver
function should be further studied.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Bruno Daniele, M.D.
Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
Italy: Ethics Committee