Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01677468
• Other study ID #: 2011-12-122
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2012
• Last updated: August 29, 2012
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2012
• Source: Hallym University Medical Center
• Contact: Sang Hoon Park, M.D., Ph.D.
• Phone: 82-2-829-5493
• Email: dr.sanghoon.park[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Description:

Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• age over 18

• ECOG performance status 0-2

• Hepatocellular carcinoma diagnosed histologically or clinically

• Tumor numbers of 5 or less

• No history of treatment for hepatocellular carcinoma

• Patients with informed consent

Exclusion Criteria:

• Extrahepatic metastasis

• Rupture of hepatocellular carcinoma

• Infiltrative hepatocellular carcinoma

• Malignancy other than hepatocellular carcinoma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Transarterial Chemoembolization

Intervention

Procedure:
• Intermediate embolization
TACE with substasis using gelfoam
• Complete embolization
TACE with complete embolization using gelfoam

Locations

Country	Name	City	State
Korea, Republic of	Hallym Sacred Heart Hospital	Anyang
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon
Korea, Republic of	Kangnam Sacred Heart Hostpita	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of the subjects	Survival rate of the subjects 6 months after TACE	6 months after TACE	No
Primary	Survival rate of the subjects	Survival rate of the subjects, 12 months after TACE	12 months after TACE	Yes
Primary	Survival rate of the subjects	Survival rate of the subjects, 18 months after TACE	18 months after TACE	Yes
Primary	Survival rate of the subjects	Survival rate of the subjects, 24 months after TACE	24 months after TACE	Yes
Secondary	Disease free survival of the subjects	Disease free survival of the subjects, 24 months after TACE	6, 12, 18, and 24 months after TACE	No
Secondary	Complication rate of TACE	The incidence of infection, hemorrhage, 24 months after TACE	6, 12, 18, and 24 months after TACE	Yes