Conditions: Carcinoma, Hepatocellular
Keywords: Cancer Liver Cancer Hepatocellular carcinoma (HCC)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 137
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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

Arms:
arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Protocol document: