- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563095
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer
July 6, 2010 updated by: Hospital Authority, Hong Kong
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Man Fung Yuen, Prof
- Phone Number: (852) 2855 5311
- Email: mfyuen@hkucc.hku.hk
Study Locations
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-
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Hong Kong, China
- Recruiting
- Queen Mary Hospital
-
Sub-Investigator:
- Ching Lung Lai, Prof
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Sub-Investigator:
- Clara Ooi, Prof
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
regression of tumour size
Time Frame: assessment every 6 months
|
assessment every 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
side effects
Time Frame: every treatment given every 8 - 12 weeks
|
every treatment given every 8 - 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Man Fung Yuen, Prof, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 23, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
July 7, 2010
Last Update Submitted That Met QC Criteria
July 6, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferons
Other Study ID Numbers
- EC 1942-02
- HARECCTR0500039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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