Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

NCT ID: NCT00646100

Last Updated: 2012-06-06

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-02-28

Brief Summary

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Transcatheter arterial chemoembolization (TACE) had been proved to improve the survivals for middle stage hepatocellular carcinoma (HCC), but for advanced stage HCC its' efficacy had not been proved. The investigators hypothesize that TACE also improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective control study to find out if the survivals for patients after TACE better than only best support or not.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACE

chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization

Group Type ACTIVE_COMPARATOR

transcatheter arterial chemoembolization

Intervention Type PROCEDURE

chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.

control

best support care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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transcatheter arterial chemoembolization

chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.

Intervention Type PROCEDURE

Other Intervention Names

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TACE

Eligibility Criteria

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Inclusion Criteria

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Tumor size \>7 cm with a portal vein invasion, and the tumor was considered to be unresectable
* No previous HCC directed treatment
* Eastern Co-operative Group performance status 0-1
* Liver function: Child's A

Exclusion Criteria

* Avascular tumor
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* underlying serve cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Diffuse-type HCC
* For patients with main portal vein occlusion, no adequate collateral circulation around the occluded portal vein
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Shi Ming

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jinqing li, MD

Role: STUDY_DIRECTOR

cancer canter sun yat-set university

Locations

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Cancer Canter Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

Reference Type BACKGROUND
PMID: 16250051 (View on PubMed)

Other Identifiers

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TACE1

Identifier Type: -

Identifier Source: org_study_id

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