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