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

This is a prospective, single arm, multi-centre, post-market clinical follow-up study to further assess safety and efficacy in 50 subjects with unresectable HCC treated with BioPearl™ microspheres loaded with Doxorubicin. All subjects will undergo clinical follow-up until disease progression and/or next treatment option, after which subjects will be followed for survival. Subjects will be followed up to a maximum of 18 months. An intermediate analysis will take place during enrollment period on safety and technical success to support regulatory requirements.

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 ≤ 7.0
• Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who is not a candidate for curative treatment at the time of study inclusion
• Subject with treatment failure/recurrence after a prior resection/ablation is permitted, with the exception of recurrence in the segment of a prior thermal ablation
• 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
• Eligible for curative treatment at the time of study inclusion
• Recurrence in the segment of a prior thermal ablation
• 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:

A. Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease

B. 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