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

Inclusion Criteria: Subject is at least 18 years old Subject with HCC confirmed by histology or according to the latest applicable version of (EASL (the European Association for the Study of the Liver) criteria Subject with tumor(s) < 5 cm and within the up to 7 criteria: the sum of the diameter of the largest tumor (in cm) and the number of tumors must be ≤ 7 (see appendix E) BCLC (Barcelona Clinic Liver Cancer) B subject or BCLC A subject not a candidate for curative treatment at the time of study inclusion or who has failed/recurred after resection/ablation. Recurrence in the segment of RFA (Radiofrequency Ablation is not allowed WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 Subject deemed treatable in one session for initial treatment Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A) Total bilirubin ≤ 2.0 mg/dl Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible) Adequate renal function: serum creatinine < 1.5 X ULN (Upper Limit of Normal) Subject has provided written informed consent Subjects of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up Exclusion Criteria: Subject previously treated with any systemic therapy for HCC Subject previously treated with intra-arterial loco-regional therapy for HCC Prior resection/ablation is allowed as per inclusion criteria 4 Eligible for curative treatment at the time of study inclusion Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status >1) History of another primary tumor. Exceptions include: 1) Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease / 2) Malignancy which occurred < 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years Subject with history of biliary tree disease or biliary dilatation Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media) Any other contraindication for embolization procedure or Doxorubicin treatment Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials In the Investigator's opinion subject has (a) co-morbid condition(s) that could limit the subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study Pregnant or breast-feeding woman