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

Primary Purpose

Hepatocellular Carcinoma Non-resectable

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
UNI-DEB
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Chonnam National University Hospital
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
  • Inha University Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • The Catholic University of Korea, Seoul ST. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UNI-DEB

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate by independent evaluator

Secondary Outcome Measures

Full Information

First Posted
May 11, 2018
Last Updated
September 27, 2018
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03533920
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Official Title
A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma Non-resectable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UNI-DEB
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
UNI-DEB
Intervention Description
Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient
Primary Outcome Measure Information:
Title
Objective Response Rate by independent evaluator
Time Frame
4 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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