Pilot Clinical Trial to Evaluate the UNI-DEB for Unresect... | NCT03564405

Studies
Pilot Clinical Trial to Evaluate the UNI-DEB for Unresectable Hepatocellular Carcinoma

NCT03564405

Sponsor

Jeil Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jun 21, 2018Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma Non-resectable

Interventions

UNI-DEB

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2016Actual

Primary Completion Date

Mar 7, 2017Actual

Completion Date

May 17, 2017Actual

First Submitted Date

Jun 11, 2018

First Submission Date that Met QC Criteria

Jun 11, 2018

First Posted Date

Jun 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2018

Last Update Posted Date

Jun 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
UNI-DEB	Experimental		Device: UNI-DEB

Name	Type	Description	Arm Group Labels	Other Names
UNI-DEB	Device	Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient	UNI-DEB

Measure	Description	Time Frame
Objective Response Rate		4 weeks after treatment

Eligibility Module

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.
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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided