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

Exclusion Criteria

• •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 control measures, during the study treatment period until survival follow-up
• •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 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
• •8. Subject with history of biliary tree disease or biliary dilatation
• •9. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal 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 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
• •13. 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
• •14. Pregnant or breast-feeding woman