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

NCT01677468 — Not applicable, Unknown, 250 participants, Hallym University Medical Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01677468
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	250 (Estimated)
Sponsor	Hallym University Medical Center (Other)
Conditions	Hepatocellular Carcinoma, Transarterial Chemoembolization
Interventions	Intermediate embolization, Complete embolization (Procedure)
Dates	start 2012-08-01, primary completion 2015-07-01 (estimated), completion 2015-07-01 (estimated), first posted 2012-09-03, last updated 2012-09-03
Locations	3 sites in South Korea

-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.

Expand all sections · Collapse all

+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Intermediate embolization	Experimental	Procedure: Intermediate embolization	TACE with substatsis using gelfoam
Complete embolization	Active comparator	Procedure: Complete embolization	TACE with complete embolization using gelfoam

Intermediate embolization (Procedure), also known as Adriamycin, Cysplatin, Gelfoam: TACE with substasis using gelfoam
Complete embolization (Procedure), also known as Adriamycin, Cysplatin, Gelfoam: TACE with complete embolization using gelfoam

+Outcome measures

Primary outcomes

Survival rate of the subjects [6 months after TACE]: Survival rate of the subjects 6 months after TACE
Survival rate of the subjects [12 months after TACE]: Survival rate of the subjects, 12 months after TACE
Survival rate of the subjects [18 months after TACE]: Survival rate of the subjects, 18 months after TACE
Survival rate of the subjects [24 months after TACE]: Survival rate of the subjects, 24 months after TACE

Secondary outcomes

Disease free survival of the subjects [6, 12, 18, and 24 months after TACE]: Disease free survival of the subjects, 24 months after TACE
Complication rate of TACE [6, 12, 18, and 24 months after TACE]: The incidence of infection, hemorrhage, 24 months after TACE

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (3)

Facility	City	Country	Status
Hallym Sacred Heart Hospital	Anyang	South Korea	Recruiting
Chuncheon Sacred Heart Hospital	Chuncheon	South Korea	Recruiting
Kangnam Sacred Heart Hostpita	Seoul	South Korea	Recruiting

+Investigators

Sang Hoon Park, M.D., Ph.D., Principal investigator, Hallym University Medical Center