Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed hepatocellular carcinoma (HCC) OR meets the
American Association for the Study of Liver Diseases (AASLD) criteria for diagnosis
of HCC

- Unresectable disease

- Not amenable to liver transplantation

- At least one uni-dimensionally measurable lesion according to the RECIST criteria by
CT scan or MRI

- Child-Pugh A (score ≤ 6) and no Child-Pugh cirrhosis C or B (score ≥ 7)

- No ascites refractory to diuretic therapy

- No documented occlusion of the hepatic artery or main portal vein

- No extrahepatic metastasis or hepatic encephalopathy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy > 3 months

- Hemoglobin ≥ 9 g/L

- Absolute neutrophil count ≥ 1.5 x 10^9/L

- Platelet count ≥ 60,000/μL

- Bilirubin ≤ 50 μmol/L

- Alkaline phosphatase < 4 times upper limit of normal (ULN)

- AST and ALT < 5 times ULN

- Creatinine ≤ 1.5 times ULN

- Amylase and lipase < 2 times ULN

- INR ≤ 1.5

- LVEF ≥ 45%

- Able to swallow oral medication

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during study and for 3 months after
completion of study treatment

- No history of bleeding within the past 4 weeks

- No contraindications for hepatic embolization procedures, including portosystemic
shunt, hepatofugal blood flow, or known severe atheromatosis

- No hypersensitivity to intravenous contrast agents

- No active clinically serious infection > grade 2 (NCI-CTC version 4)

- No known history of HIV infection

- No history of second malignancy except non-melanotic skin cancer or cervical
carcinoma in situ or malignancy treated with curative intent with > 3 years without
relapse

- No evidence of severe or uncontrolled disease including any of the following:

- Systemic disease

- Cardiac arrhythmias (requiring anti-arrhythmic therapy or pacemaker)

- Hypertension

- NYHA class III or IV congestive cardiac failure

- Myocardial infarction within the past 6 months

- Laboratory finding that, in the view of the Investigator, makes it undesirable
for the patient to participate in the trial

- No psychiatric or other disorder likely to impact on informed consent

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior and no concurrent investigational therapy

- No prior embolization, systemic therapy, or radiotherapy for HCC

- No major surgery within the past 4 weeks

- No ablative therapy (radiofrequency ablation or percutaneous ethanol injection) for
HCC

- Patients with untreated target lesion(s) and ablation occurred > 6 weeks prior
to study entry allowed

- No concurrent rifampicin or St. John wort

- No concurrent bone marrow transplant or stem cell rescue

- No concurrent bevacizumab or drugs that target VEGF or VEGF receptors

- No other concurrent anticancer chemotherapy, immunotherapy, hormone therapy, or
molecular therapy except bisphosphonates