Conditions: Carcinoma, Hepatocellular
Keywords: Sorafenib (Nexavar) Erlotinib (Tarceva) First Line HCC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 732
Healthy volunteers: no

Brief summary:
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Detailed description:
European quality of life scale (5 dimensions) (EQ-5D)

Arms:
arm 1: Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd) arm 2: Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Erlotinib (Tarceva) intervention 3: Placebo
Intervention descriptions: intervention 1: Sorafenib 400 mg twice daily intervention 2: Erlotinib 150 mg once daily intervention 3: Matching erlotinib placebo 150 mg once daily

Protocol document: