A Comparative Study of the Efficacy of Transcatheter Arte... | NCT00563095

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

NCT00563095

Sponsor

Hospital Authority, Hong Kong

Status

Unknown status

Last Update Posted

Jul 7, 2010Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Carcinoma, Hepatocellular

Interventions

Transcatheter Arterial Chemoembolization (TACE)
Transcatheter Arterial Pegylated Interferon Embolization (TAIE)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
HARECCTR0500039

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 23, 2007

First Posted Date

Nov 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Name	Class
Schering-Plough	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Arterial Chemoembolization (TACE)	Procedure
Transcatheter Arterial Pegylated Interferon Embolization (TAIE)	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
regression of tumour size		assessment every 6 months

Secondary Outcomes

Measure	Description	Time Frame
side effects		every treatment given every 8 - 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Man Fung Yuen, Prof	Contact	(852) 2855 5311		mfyuen@hkucc.hku.hk

Overall Officials

Name	Affiliation	Role
Man Fung Yuen, Prof	Department of Medicine, Queen Mary Hospital/ The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital	Recruiting	Hong Kong			China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases