Carcinoma, HepatocellularNCT00563095
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer
A study testing Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) in people with Carcinoma, Hepatocellular, run by Hospital Authority, Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Confirmed hepatocellular carcinoma not suitable for surgery
Who cannot join
- Portal vein thrombosis
- Severe arteriovenous shunt
- Bilirubin level > 50 umol/mL
- Prothrombin time > 5 seconds
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Ching Lung Lai, Prof
Clara Ooi, Prof
About this study
Official title: A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Transcatheter Arterial Chemoembolization (TACE), Transcatheter Arterial Pegylated Interferon Embolization (TAIE)
- Keywords
- Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial Chemoembolization (TACE)Procedure or surgery
Transcatheter Arterial Pegylated Interferon Embolization (TAIE)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
regression of tumour size
Measured: assessment every 6 months
Secondary outcomes (1)
side effects
Measured: every treatment given every 8 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startMar 2004
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Schering-Plough
- Investigators
- Man Fung Yuen, Prof, Principal investigator, Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563095
- Sponsor's protocol ID
- EC 1942-02
- Other IDs
- HARECCTR0500039
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00563095
- Acronym / sponsor ID
- EC 1942-02
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Schering-Plough
- Study start
- Mar 2004
- Study completion
- Dec 2008 (estimated)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed hepatocellular carcinoma not suitable for surgery
Key exclusion criteria (4 listed)
- Portal vein thrombosis
- Severe arteriovenous shunt
- Bilirubin level > 50 umol/mL
- Prothrombin time > 5 seconds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Arterial Chemoembolization (TACE) | Procedure or surgery | – |
| Transcatheter Arterial Pegylated Interferon Embolization (TAIE) | Procedure or surgery | – |
Primary outcome
regression of tumour size
Time frame: assessment every 6 months
1 secondary outcome
side effects
Time frame: every treatment given every 8 - 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Fung Yuen, Prof principal investigator
Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) in people with Carcinoma, Hepatocellular, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Man Fung Yuen, Prof ((852) 2855 5311, mfyuen@hkucc.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regression of tumour size (time frame: assessment every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.