Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation

Inclusion criteria * Patients with a confirmed diagnosis of HCC according to the EASL criteria for diagnosis, see appendix 4 and staged according to the BCLC criteria. * Patient chooses to participate and has signed the informed consent document * Age above 18 years old * Patients with HCC not suitable for resection or percutaneous ablation according to the BCLC Staging classification, see Figure 2. * Patient is eligible for resection or percutaneous ablation but the treatment is unfeasible or the patient has declined. This decision must be documented in the patient's records. * Patient is eligible for chemoembolisation prior to transplantation and the expected transplant waiting time exceeds 6 months. * Patients who demonstrates recurrence following potentially curative treatment (resection and percutaneous ablation) who have clearly measurable disease according to RECIST or EASL * Patients with Performance Status ECOG 0 and 1 * Patients with well preserved liver function (Child-Pugh A and B) * Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3 weeks. Exclusion criteria * Patients with another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia * Patients previously treated with transarterial embolisation (with or without chemotherapy). * Patients previously treated with anthracyclines (ie doxorubicin). * Patients' whose only measurable disease is within an area of the liver previously subjected to radiotherapy. * Advanced liver disease: * Child-Pugh C, * active gastrointestinal bleeding, * encephalopathy or clinically relevant ascites. * Bilirubin levels \>3mg/dl * Advanced tumoural disease: * BCLC class C, (vascular invasion including segmental portal obstruction, extrahepatic spread or cancer-related symptoms= ECOG 2, 3 and 4) or * BCLC class D (WHO performance status 3 or 4, Okuda III stage) or * Diffuse HCC defined as \>50% tumour involvement of the whole liver * Any contraindication for doxorubicin administration: * serum bilirubin \>5mg/dL, * WBC \<3000 cells/mm3 * neutrophil \<1500 cells/mm3, * cardiac ejection fraction \<50 percent assessed by isotopic ventriculography, echocardiography or MRI * Any contraindication for hepatic embolisation procedures: * porto-systemic shunt, * hepatofugal blood flow; * impaired clotting tests (platelet count \<50000/mm3, prothrombin activity \<50 percent), * renal insufficiency/failure, serum creatinine \> 2mg/dl (177umol/l) * severe atheromatosis, * AST and/or ALT \>5x ULN or, when greater \>250U/l * Women who are pregnant or breast feeding * Allergy to contrast media * Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation * The availability of alternative therapies those, in the judgment of the physician (referring or treating), are more appropriate for the patient * Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk, that would preclude the safe use of DC Bead™, or TACE * Patients who are contraindicated for MRI