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CompletedNCT00646100TACEHCCUpdated Jun 6, 2012

Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

A Phase 4 interventional study of transcatheter arterial chemoembolization in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
164
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • hepatocellular carcinoma
  • transcatheter arterial chemoembolization
  • prospective control study
  • best support care
  • survival
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 164 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
164 participants (actual)

Study arms

  • Active comparator
    TACE

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

    Procedure: transcatheter arterial chemoembolization

  • No intervention
    control

    best support care

Interventions

  • Proceduretranscatheter arterial chemoembolization

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

    Also known as: TACE

06

What researchers measure

Primary outcomes

  1. survival rates

    Time frame: 6, 12 months

Secondary outcomes

  1. quality of life

    Time frame: 6, 12 months

07

Study locations

1 site
  • Cancer Canter Sun Yat-Sen University
    Guangzhou, Guangdong 510060, China
08

References and documents

Publications

  • 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. PubMed 16250051 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00646100
Lead sponsor
Sun Yat-sen University
Responsible party
Shi Ming (Professor, Sun Yat-sen University) — Principal investigator
First posted
Mar 28, 2008
Start date
Jul 2007
Primary completion
Jul 2009
Completion
Feb 2010
Last update
Jun 6, 2012

Study contacts

jinqing li, MD
study director · cancer canter sun yat-set university

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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