A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:

• Pharmacokinetics (PK) profile of Sorafenib
• Plasma and tissue tumor biomarkers

Inclusion Criteria:

• Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
• Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
• Measurable disease
• At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
• Presence of at least 1 of the following:
• Alpha-fetoprotein greater than the upper limit of normal (ULN)
• Hepatitis C antibody positive
• Hepatitis B surface antigen positive
• Child's Pugh class A or B
• Candidate for systemic therapy

Exclusion Criteria:

• Fibrolamellar disease mixed histology
• Metastatic brain or meningeal tumors