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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03564405
Other study ID # UNI-DEB-Pilot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2016
Est. completion date May 17, 2017

Study information

Verified date June 2018
Source Jeil Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 17, 2017
Est. primary completion date March 7, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Catholic University Seoul St. Mary Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate 4 weeks after treatment
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