NCT03564405

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

June 11, 2018

Last Update Submit

June 19, 2018

Conditions

Hepatocellular Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    4 weeks after treatment

Study Arms (1)

UNI-DEB

EXPERIMENTAL
Device: UNI-DEB

Interventions

UNI-DEBDEVICE

Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient

UNI-DEB

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • 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
  • ANC \< 1,500cells/mm3
  • Platelet \< 50,000mm3
  • Serum creatinine \> 2mg/dL
  • INR \> 1.4
  • ALT and AST \> 5 times UNL
  • Diffuse HCC defined as \>50% tumor involvement of the whole liver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University Seoul St. Mary Hospital

Seoul, South Korea

Location

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

June 11, 2018

First Posted

June 20, 2018

Study Start

December 5, 2016

Primary Completion

March 7, 2017

Study Completion

May 17, 2017

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)