prospective randomised study of doxorubicin in the treatment of hepatocellular carcinoma by drug-eluting bead embolisation

Conditions: Primary Liver Cancer

Summary: the objective of this study is to assess the safety and efficacy of dc bead™ delivered by intra-arterial embolisation for the treatment of hepatocellular carcinoma


Eligibility criteria:
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

Keywords: hepatocellular carcinoma (hcc)