Hepatocellular Carcinoma Non-resectable
Conditions
Brief summary
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Interventions
DEVICEUNI-DEB
Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient
Sponsors
Jeil Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate by independent evaluator | 4 weeks after treatment |
Countries
South Korea
Outcome results
None listed