Back to resultsTransarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (TACEHCC)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
transcatheter arterial chemoembolization
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, transcatheter arterial chemoembolization, prospective control study, best support care, survival
Eligibility 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
Sites / Locations
- Cancer Canter Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
TACE
control
Arm Description
chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization
best support care
Outcomes
Primary Outcome Measures
survival rates
Secondary Outcome Measures
quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646100
Brief Title
Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Acronym
TACEHCC
Official Title
Transarterial Chemoembolization Versus Best Support for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, transcatheter arterial chemoembolization, prospective control study, best support care, survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TACE
Arm Type
Active Comparator
Arm Description
chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization
Arm Title
control
Arm Type
No Intervention
Arm Description
best support care
Intervention Type
Procedure
Intervention Name(s)
transcatheter arterial chemoembolization
Other Intervention Name(s)
TACE
Intervention Description
chemo-lipiodolization with EADM 50mg, Lobaplatin 50mg, and MMC 6mg,plus particleembolization.
Primary Outcome Measure Information:
Title
survival rates
Time Frame
6, 12 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jinqing li, MD
Organizational Affiliation
cancer canter sun yat-set university
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Canter Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
16250051
Citation
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.
Results Reference
background
Learn more about this trial
Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
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