A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00563095
• Collaborator: Schering-Plough (Industry)
• Enrollment: 100
• Location: 1
• Duration (Months): 57
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Procedure: Transcatheter Arterial Chemoembolization (TACE); Procedure: Transcatheter Arterial Pegylated Interferon Embolization (TAIE)	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2004
• Anticipated Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. regression of tumour size [assessment every 6 months]

Secondary Outcome Measures

1. side effects [every treatment given every 8 - 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		China

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563095
• Other Study ID Numbers: EC 1942-02; HARECCTR0500039
• First Posted: Nov 26, 2007
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Hepatocellular carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Interferons

Study Results

No Results Posted as of Jul 7, 2010