NCT00563095

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • regression of tumour size

    assessment every 6 months

Secondary Outcomes (1)

  • side effects

    every treatment given every 8 - 12 weeks

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed hepatocellular carcinoma not suitable for surgery

You may not qualify if:

  • Portal vein thrombosis
  • Severe arteriovenous shunt
  • Bilirubin level \> 50 umol/mL
  • Prothrombin time \> 5 seconds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Man Fung Yuen, Prof

    Department of Medicine, Queen Mary Hospital/ The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Man Fung Yuen, Prof

CONTACT

(852) 2855 5311mfyuen@hkucc.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

March 1, 2004

Study Completion

December 1, 2008

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(1)