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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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ClinicalTrials.gov Identifier: NCT00563095
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Hospital Authority, Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Procedure: Transcatheter Arterial Chemoembolization (TACE) Procedure: Transcatheter Arterial Pegylated Interferon Embolization (TAIE) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma
Study Start Date : March 2004
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. regression of tumour size [ Time Frame: assessment every 6 months ]

Secondary Outcome Measures :
  1. side effects [ Time Frame: every treatment given every 8 - 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00563095


Contacts
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Contact: Man Fung Yuen, Prof (852) 2855 5311 mfyuen@hkucc.hku.hk

Locations
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China
Queen Mary Hospital Recruiting
Hong Kong, China
Sub-Investigator: Ching Lung Lai, Prof         
Sub-Investigator: Clara Ooi, Prof         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Schering-Plough
Investigators
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Principal Investigator: Man Fung Yuen, Prof Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00563095    
Other Study ID Numbers: EC 1942-02
HARECCTR0500039
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010
Keywords provided by Hospital Authority, Hong Kong:
Hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents