Pilot Clinical Trial to Evaluate the UNI-DEB for Unresectable Hepatocellular Carcinoma

Jeil Pharmaceutical

Status: Completed

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Device: UNI-DEB

Study type: Interventional

Funder types: Industry

Identifiers

NCT03564405

UNI-DEB-Pilot

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.
• 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
• ANC < 1,500cells/mm3
• Platelet < 50,000mm3
• Serum creatinine > 2mg/dL
• INR > 1.4
• ALT and AST > 5 times UNL
• Diffuse HCC defined as >50% tumor involvement of the whole liver.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

UNI-DEB

Experimental group

Treatment:

Device: UNI-DEB