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

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533920
• Other study ID #: UNI-DEB-Pivotal
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: September 3, 2018

Study information

• Verified date: September 2018
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 3, 2018
• Est. primary completion date: June 30, 2018
• 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 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.

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

• 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.

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	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital	Gyeonggi-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul ST. Mary's 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 by independent evaluator		4 weeks after treatment