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

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

A Open, Single-arm, Uncontrolled, Single Center, Pilot Study to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564405
• Other study ID #: UNI-DEB-Pilot
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

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