Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized Hepatocellular Cancer

Inclusion Criteria

• Confirmed hepatocellular cancer (HCC) by pathology or by NCCN imaging guidelines
• All HCC stages are allowed. May be a liver transplant candidate.
• At least one tumor (index tumor) accurately measured as 3.5-7cm in diameter (long and short axis diameter to be recorded, but only one needs to meet this criteria) on baseline imaging.
• No prior therapy for the index tumor
• No prior systemic treatment for HCC within 4 weeks and no prior anti-VEGF therapy within 8 weeks of study entry.
• Life expectancy > 8 weeks.
• ECOG >=0 or 1
• RFA clinically indicated for index tumor.
• Acceptable overall RFA and anesthesia risk.
• Adequate bone marrow, liver and renal function: Hemoglobin >9.0 g/dl; Absolute neutrophil count (ANC)>1,500/mm3; Platelet count correctable to >50,000/mm3; compensated liver function (Child-Turcotte-Pugh A, B7 or B8); Creatinine <1.5 times ULN; INR correctable to <1.5.
• Ability to take oral medication and no evidence of impaired absorption.

Exclusion Criteria

• Urgent treatment of the index tumor anticipated.
• Participants who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Participants currently receiving any other study agents.
• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib.
• Participants receiving medications or substances that are inducers of CYP3A4 (rifampicin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone) or that are metabolized/eliminated by predominantly UGT1A1 pathway or by CYP2B6 and CYP2C8.
• Decompensated liver disease
• Uncontrolled hypertension
• Thrombolic or embolic events within the past 6 months.
• Hemorrhage/bleeding event within 4 weeks
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence of severe or uncorrectable bleeding diathesis or coagulopathy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of study entry.
• Contraindication to or inability to undergo the RFA procedure,
• Contraindication to or inability to undergo imaging with MRI
• Uncontrolled intercurrent illness
• Individuals with a history of a different malignancy unless disease-free for at least 5 years and are deemed by the Investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
• HIV-positive individuals on combination antiretroviral therapy

For additional inclusion/exclusion criteria details contact Study Site.