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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563095
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
Carcinoma, Hepatocellular
 Procedure: Transcatheter Arterial Chemoembolization (TACE)
Procedure: Transcatheter Arterial Pegylated Interferon Embolization (TAIE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Interferon
U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • regression of tumour size [ Time Frame: assessment every 6 months ]

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

Estimated Enrollment: 100
Study Start Date: March 2004
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563095

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

Locations
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
Principal Investigator: Man Fung Yuen, Prof Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
  More Information

Additional Information:
HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00563095     History of Changes
Other Study ID Numbers: EC 1942-02, HARECCTR0500039
Study First Received: November 21, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Hepatocellular carcinoma

Additional relevant MeSH terms:
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
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013