BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

1. Subject is at least 18 years old

2. Subject with HCC confirmed by histology or according to the latest applicableversion of EASL (the European Association for the Study of the Liver) criteria

3. Subject with tumor(s) < 5 cm and within the up-to-7 criteria: the sum of thediameter of the largest tumor (in cm) and the number of tumors must be ≤ 7.0

4. Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who isnot a candidate for curative treatment at the time of study inclusion

5. Subject with treatment failure/recurrence after a prior resection/ablation ispermitted, with the exception of recurrence in the segment of a prior thermalablation

6. WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group)performance status 0 or 1

7. Subject deemed treatable in one session for initial treatment

8. Normal liver or compensated cirrhosis with preserved liver function (Child-PughClass A)

9. Total bilirubin ≤ 2.0 mg/dl

10. Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L

11. Subject with no ascites or with minor ascites controlled by sodium dietaryrestrictions (subject receiving diuretic treatment or paracentesis is not eligible)

12. Adequate renal function: serum creatinine < 1.5 X ULN (Upper Limit of Normal)

13. Subject has provided written informed consent

14. Subjects of childbearing/reproductive potential should use adequate birth controlmeasures, during the study treatment period until survival follow-up

Exclusion Criteria:

1. Subject previously treated with any systemic therapy for HCC

2. Subject previously treated with intra-arterial loco-regional therapy for HCC

3. Eligible for curative treatment at the time of study inclusion

4. Recurrence in the segment of a prior thermal ablation

5. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding,encephalopathy

6. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental,extra-hepatic spread or cancer-related symptoms performance status >1)

7. History of another primary tumor. Exceptions include: A. Malignancy treated with curative intent ≥ 5 years before inclusion and with noknown active disease B. Malignancy which occurred < 5 years before, not active and not expected to recuror be clinically relevant in the next 5 years

8. Subject with history of biliary tree disease or biliary dilatation

9. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absentportal blood flow in the liver area to be treated

10. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media)

11. Any other contraindication for embolization procedure or Doxorubicin treatment

12. Subject is currently participating in an investigational drug or device study thathas not completed the primary endpoint or that clinically interferes with thecurrent study endpoints Note: Trials requiring extended follow-up for products that were investigational,but have become commercially available since then, are not consideredinvestigational trials

13. In the Investigator's opinion subject has (a) co-morbid condition(s) that couldlimit the subject's ability to participate in the study, compliance with follow-uprequirements or impact the scientific integrity of the study

14. Pregnant or breast-feeding woman