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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00646100
First received: March 25, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646100

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

Publications:
Bruix J, Sherman M. Management of hepatocellular carcinoma. Hepatology 2005; 42:1208-1236.

Responsible Party: Shi Ming, Professor, Sun Yat-sen University
ClinicalTrials.gov 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
survival

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

ClinicalTrials.gov processed this record on July 23, 2014