Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Not Applicable
Completed
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Interventions
- Device: UNI-DEB
- Registration Number
- NCT03533920
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Brief Summary
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description UNI-DEB UNI-DEB -
- Primary Outcome Measures
Name Time Method Objective Response Rate by independent evaluator 4 weeks after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of