A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion.

Summary:

The purpose of this study is to see if adding the oral chemotherapy pill, sorafenib (Nexavar), to localized chemotherapy (chemoembolization) to the liver will help patients to live longer than treatment with localized chemotherapy to the liver without sorafenib. Sorafenib is currently approved by the United States Food and Drug Administration for the treatment of liver cancer. It is not known if the combination of chemoembolization and sorafenib will work better than chemoembolization alone.

Subjects eligible for this study will receive 1 of 2 treatments:

ARM A:  Sorafenib + Chemoembolization

                                    OR

ARM B:  Placebo + Chemoembolization

Eligibility and Treatment Plan:

1. Subjects must have hepatocellular carcinoma limited to the liver
2. Subjects must be at least 18 years old.
3. Subjects may NOT have been previously treated with sorafenib, chemoembolization, or systemic chemotherapy.