Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
1 other identifier
interventional
62
1 country
8
Brief Summary
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2017
CompletedFirst Submitted
Initial submission to the registry
May 11, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2018
CompletedOctober 1, 2018
September 1, 2018
8 months
May 11, 2018
September 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate by independent evaluator
4 weeks after treatment
Study Arms (1)
UNI-DEB
EXPERIMENTALInterventions
Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Gyeonggi-do, South Korea
Inha University Hospital
Incheon, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2018
First Posted
May 23, 2018
Study Start
October 25, 2017
Primary Completion
June 30, 2018
Study Completion
September 3, 2018
Last Updated
October 1, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share