DC Bead LUMI (TM) Loaded With Doxorubicin for Intermediate Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

1. Patient is at least 18 years old.
2. HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
3. Barcelona Criteria Liver Cancer (BCLC) stage B patients or BCLC stage A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation).
4. Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
5. Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/1.
6. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A score and Child/Pugh B≤ 7 points ) without ascites.
7. Total bilirubin ≤2.0 mg/dl.
8. Adequate renal function (serum creatinine \< 1.5 X ULN).
9. Patient has provided written informed consent.

Exclusion Criteria:

1. Patient previously treated with any intra-arterial therapy for HCC.
2. Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
3. Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels \>2.0 mg/dl.
4. Advanced tumoural disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=ECOG of 1-2) or D class (WHO performance status 3 or 4, Okuda III stage).
5. Patient with another primary tumour.
6. Patient with refractory ascites or on diuretic treatment; minor ascites retention detected at imaging and not requiring diuretics to be solved is not a contraindication.
7. Patient with history of biliary tree disease or biliary dilatation.
8. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
9. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
10. Any other contraindication for embolisation or local doxorubicin treatment.
11. Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before study treatment.
12. In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
13. Pregnant or breast-feeding women.