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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646100
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: transcatheter arterial chemoembolization Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transarterial Chemoembolization Versus Best Support for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Study Start Date : July 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. survival rates [ Time Frame: 6, 12 months ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: 6, 12 months ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Shi Ming, Professor, Sun Yat-sen University Identifier: NCT00646100     History of Changes
Other Study ID Numbers: TACE1
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases