Thymostimulin versus placebo for treatment of advanced hepatocellular carcinoma: A randomized, controlled, double-blind, multicenter study

Aims: Thymostimulin is a thymic peptide fraction with immune-mediated cytotoxicity against hepatocellular carcinoma (HCC) in vitro and palliative efficacy in advanced HCC in two independent phase II trials. The aim of this study was to assess its efficacy in a phase III trial. Methods: Patients (age 18 to 75 years) with biopsy-proven HCC not amenable to or failing local and surgical therapy were randomized to receive thymostimulin 75mg s.c. five times per week or placebo for one year or until progression. Exclusion criteria were Karnofsky score 5mg/dl, INR >2.2). Primary endpoint was overall survival, secondary…