Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Inclusion Criteria:

• Over 19 years
• Diagnosis of HCC
• Unresectable asymtomatic uninodular or multinodular tumor.
• Subject who maintain clinically normal hepatopetal flow without main portal vein closure
• At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less.
• ECOG Performance Status of 0 or 1.
• Child-Pugh class A or B
• Life expectancy of at least 6 months.

Exclusion Criteria:

• Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
• Hepatic resection, liver transplantation or Percutaneous local treatment
• Previously received HCC related medical procedure
• Previously treated with anthracyclines
• Only measurable disease is within an area of the liver previously subjected to radiotherapy.
• Child Pugh C
• Active gastrointestinal bleeding within 6 months from screening.
• Total bilirubin > 3mg/dL
• WBC < 3,000cells/mm3
• Platelet < 50,000mm3
• Serum creatinine > 2mg/dL
• INR> 1.4
• ALT and AST > 5 times UNL
• Diffuse HCC defined as >50% tumour involvement of the whole liver.