Transarterial Chemoembolization Using Doxorubicin Beads With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

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