Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (TACEHCC)

This study has been completed.
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University Identifier:
First received: March 25, 2008
Last updated: June 5, 2012
Last verified: June 2012

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.

Condition Intervention Phase
Hepatocellular Carcinoma
Procedure: transcatheter arterial chemoembolization
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transarterial Chemoembolization Versus Best Support for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • survival rates [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 164
Study Start Date: July 2007
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TACE
chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization
Procedure: transcatheter arterial chemoembolization
chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.
Other Name: TACE
No Intervention: control
best support care


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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:

  • 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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Please refer to this study by its identifier: NCT00646100

China, Guangdong
Cancer Canter Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Study Director: jinqing li, MD cancer canter sun yat-set university
  More Information

Responsible Party: Shi Ming, Professor, Sun Yat-sen University Identifier: NCT00646100     History of Changes
Other Study ID Numbers: TACE1
Study First Received: March 25, 2008
Last Updated: June 5, 2012
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
transcatheter arterial chemoembolization
prospective control study
best support care

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on October 13, 2015