• Time to symptomatic progression [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Time to progression [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Overall disease control rate [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Patient report outcomes [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Overall response rate (proportion of patients with confirmed partial and complete responses) [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Overall response duration duration and time to objective response [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Time to response, Pharmacokinetic profile, Safety, [ Time Frame: follow up visit ] [ Designated as safety issue: No ]
• Evaluate possible and potentially predictive assays of clinical benefit through an exploratory assessment of the correlation between the defined baseline characteristics and key clinical endpoints. [ Time Frame: screening, C3D1, EOT ] [ Designated as safety issue: Yes ]
• Correlation between the following baseline characteristics and key clinical endpoints (i.e., response, TTP, TTSP, and OS): tumor pERK, phospho VEGF-R2 concentration, plasma proteomics, and gene expression profiling of blood cells and tumor biopsies [ Time Frame: follow up visit ] [ Designated as safety issue: No ]

• Time to symptomatic progression, time to progression, disease control rate, Patient report outcomes, overall response rate, overall response duration, time to response, PK profile [ Time Frame: Aug.2007-Nov.2007 ]
• Correlation between the following baseline characteristics and key clinical endpoints (i.e., response, TTP, TTSP, and OS): tumor pERK, phospho VEGF-R2 concentration, plasma proteomics, and gene expression profiling of blood cells and tumor biopsies [ Time Frame: Aug.2007-Nov.2007 ]

The purpose of the study is

• Find out if patients receiving sorafenib will live longer
• Find out if sorafenib has any effect on patient reported outcomes
• Find out if sorafenib prevents the growth or shrinks liver tumors and / or their metastases
• Determine the pharmacokinetics (PK) in patients with liver cancer

• Drug: Nexavar (Sorafenib, BAY43-9006)
• Drug: Placebo

Inclusion Criteria:

• Ages eligible for study: 18 years and above, Genders eligible for study: both
• Patients who have a life expectancy of at least 12 weeks
• Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented

• Patients must have at least one tumor lesion that meets both of the following criteria

  1. Accurately measured in at least one dimension according to RECIST
  2. Not been previously treated with local therapy
• Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan
• Patients who have an ECOG Performance Status of 0, 1, or 2

Exclusion Criteria:

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
• History of cardiac disease
• Active clinically serious infections
• Known history of HIV infection
• Known CNS tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry