Sorafenib plus tegafur-uracil (UFT) versus sorafenib as first line systemic treatment for patients with advanced stage HCC: a Phase II trial (ESLC01 study).

ABSTRACT:

Background

Phase II trials found that tegafur-uracil (UFT) is an effective drug in hepatocellular carcinoma (HCC), while preclinical data suggested that its combination with sorafenib may have a promising activity. Our Phase II randomized trial aimed to evaluate efficacy and tolerability of sorafenib plus UFT vs sorafenib in advanced HCC.

Methods

Patients with advanced HCC, with no prior systemic therapy, were randomized to receive either UFT at 125 mg/m² twice daily for 4 out of 5 weeks plus sorafenib at 400 mg twice daily (arm 1) or single agent sorafenib at 400 mg twice daily (arm 2). Primary end point was time to progression (TTP).

Results

Between March 2012 and March 2014, 76 eligible patients - out of 143 preplanned - were randomized. The study was te

SUBMITTER: Azim HA 

PROVIDER: S-EPMC6250115 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature