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NCT00563095 Clinical Trial

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

Carcinoma, Hepatocellular Clinical Trial

Official title:
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00563095
Other study ID # EC 1942-02
Secondary ID HARECCTR0500039
Status Recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date March 2004
Est. completion date December 2008

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Man Fung Yuen, Prof
Phone (852) 2855 5311
Email mfyuen@hkucc.hku.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Transcatheter Arterial Chemoembolization (TACE)

• Transcatheter Arterial Pegylated Interferon Embolization (TAIE)

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Schering-Plough

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary regression of tumour size assessment every 6 months
Secondary side effects every treatment given every 8 - 12 weeks
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