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

NCT ID: NCT01677468

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Transarterial Chemoembolization

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hepatocellular carcinoma Transarterial chemoembolization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermediate embolization

TACE with substatsis using gelfoam

Group Type EXPERIMENTAL

Intermediate embolization

Intervention Type PROCEDURE

TACE with substasis using gelfoam

Complete embolization

TACE with complete embolization using gelfoam

Group Type ACTIVE_COMPARATOR

Complete embolization

Intervention Type PROCEDURE

TACE with complete embolization using gelfoam

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intermediate embolization

TACE with substasis using gelfoam

Intervention Type PROCEDURE

Complete embolization

TACE with complete embolization using gelfoam

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Adriamycin Cysplatin Gelfoam Adriamycin Cysplatin Gelfoam

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sang Hoon Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hallym Sacred Heart Hospital

Anyang, , South Korea

Site Status RECRUITING

Chuncheon Sacred Heart Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Kangnam Sacred Heart Hostpita

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sang Hoon Park, M.D., Ph.D.

Role: CONTACT

Phone: 82-2-829-5493

Email: [email protected]

Su Rin Shin, M.D.

Role: CONTACT

Phone: 82-2-829-5490

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Choong Kee Park, M.D., Ph.D.

Role: primary

Dong Joon Kim, M.D., Ph.D.

Role: primary

Sang Hoon Park, M.D., Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-12-122

Identifier Type: -

Identifier Source: org_study_id