Suspended

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

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What is being tested

Intermediate embolization

+ Complete embolization

Procedure
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

Over 19 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorHallym University Medical Center
Study ContactSang Hoon Park, M.D., Ph.D.More contacts
Last updated: September 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01677468
Principal SponsorHallym University Medical Center
Study ContactSang Hoon Park, M.D., Ph.D.More contacts
Last updated: September 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialCarcinoma, Hepatocellular

Criteria

6 inclusion criteria required to participate
ECOG performance status 0-2
Hepatocellular carcinoma diagnosed histologically or clinically
No history of treatment for hepatocellular carcinoma
Patients with informed consent
Show More Criteria
4 exclusion criteria prevent from participating
Extrahepatic metastasis
Infiltrative hepatocellular carcinoma
Malignancy other than hepatocellular carcinoma
Rupture of hepatocellular carcinoma

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
TACE with substatsis using gelfoam

Group II

Active Comparator
TACE with complete embolization using gelfoam

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Hallym Sacred Heart Hospital

Anyang, South KoreaOpen Hallym Sacred Heart Hospital in Google Maps
Recruiting

Chuncheon Sacred Heart Hospital

Chuncheon, South Korea
Recruiting

Kangnam Sacred Heart Hostpita

Seoul, South Korea
Suspended3 Study Centers