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

September 27, 2018 updated by: Jeil Pharmaceutical Co., Ltd.

A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UNI-DEB
Device: UNI-DEB
Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate by independent evaluator
Time Frame: 4 weeks after treatment
4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

September 3, 2018

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 11, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNI-DEB-Pivotal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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