102 unresectable or metastatic BTC patients with histologically proven adenocarcinoma of gallbladder or intrahepatic bile ducts , Eastern Cooperative Oncology Group ( ECOG ) 0-2 were randomised to gemcitabine ( 1000 mg/m2 once weekly , first 7-weeks +1 - week rest followed by once 3-weeks +1 - week rest ) plus sorafenib ( 400 mg twice daily ) or placebo .