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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma, Transarterial Chemoembolization

Intervention / Treatment
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* Procedure: Intermediate embolization
* Procedure: Complete embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermediate embolization<br>TACE with substatsis using gelfoam | Procedure: Intermediate embolization<br>* TACE with substasis using gelfoam<br>* Other names: Gelfoam;|
| Active Comparator: Complete embolization<br>TACE with complete embolization using gelfoam | Procedure: Complete embolization<br>* TACE with complete embolization using gelfoam<br>* Other names: Gelfoam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of the subjects | Survival rate of the subjects 6 months after TACE | 6 months after TACE | 
| Survival rate of the subjects | Survival rate of the subjects, 12 months after TACE | 12 months after TACE | 
| Survival rate of the subjects | Survival rate of the subjects, 18 months after TACE | 18 months after TACE | 
| Survival rate of the subjects | Survival rate of the subjects, 24 months after TACE | 24 months after TACE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival of the subjects | Disease free survival of the subjects, 24 months after TACE | 6, 12, 18, and 24 months after TACE | 
| Complication rate of TACE | The incidence of infection, hemorrhage, 24 months after TACE | 6, 12, 18, and 24 months after TACE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Transarterial chemoembolization