Back to resultsA Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer
Primary Purpose
Carcinoma, Hepatocellular
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcatheter Arterial Chemoembolization (TACE)
Transcatheter Arterial Pegylated Interferon Embolization (TAIE)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular carcinoma
Eligibility Criteria
Inclusion Criteria:
- Confirmed hepatocellular carcinoma not suitable for surgery
Exclusion Criteria:
- Portal vein thrombosis
- Severe arteriovenous shunt
- Bilirubin level > 50 umol/mL
- Prothrombin time > 5 seconds
Sites / Locations
- Queen Mary HospitalRecruiting
Outcomes
Primary Outcome Measures
regression of tumour size
Secondary Outcome Measures
side effects
Full Information
NCT ID
NCT00563095
First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00563095
Brief Title
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer
Official Title
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Schering-Plough
4. Oversight
5. Study Description
Brief Summary
Primary: To compare the efficacy of TACE and TAIE.
Secondary: To compare the side effects of TACE and TAIE.
The outcome measurements include survival benefit and tumour regression induced by the two therapies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Hepatocellular carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Transcatheter Arterial Chemoembolization (TACE)
Intervention Type
Procedure
Intervention Name(s)
Transcatheter Arterial Pegylated Interferon Embolization (TAIE)
Primary Outcome Measure Information:
Title
regression of tumour size
Time Frame
assessment every 6 months
Secondary Outcome Measure Information:
Title
side effects
Time Frame
every treatment given every 8 - 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Confirmed hepatocellular carcinoma not suitable for surgery
Exclusion Criteria:
Portal vein thrombosis
Severe arteriovenous shunt
Bilirubin level > 50 umol/mL
Prothrombin time > 5 seconds
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Man Fung Yuen, Prof
Phone
(852) 2855 5311
Email
mfyuen@hkucc.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Man Fung Yuen, Prof
Organizational Affiliation
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching Lung Lai, Prof
First Name & Middle Initial & Last Name & Degree
Clara Ooi, Prof
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer
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