Objective To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma (HCC).Methods In this three-center open-label study from November 2011 to May 2013

we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups

one group with 95 patient to receive sorafenib (400 mg a time

twice a day) and the other group with 94 patients to receive best supportive care. The primary end points were progression-free survival and overall survival.Results The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group

0.55; 95% confidence interval

0.40-0.75; P=0.002). The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively (Hazard ratio in the sorafenib group

0.48; 95% confidence interval

0.35-0.68; P<0.001). The main adverse effect of sorafenib was rash and acne of the skin (in 51.7% patients). The incidences of severe rash

diarrhea

and dry skin were 5.6%

5.6%

and 2.2% in the sorafenib group. One patient reached partial response in the sorafenib group.Conclusions Sorafenib is safe in patients with liver function impaired advanced HCC. It is effective in terms of progression-free survival and overall survival compared with best supportive care. Liver functions are the important predictive factors.