Hepatocellular CarcinomaPhase 3NCT00467974
Transarterial Ethanol Ablation (TEA) Versus Transcatheter Arterial Chemoembolisation (TACE) for Hepatocellular Carcinoma
A Phase 3 study testing TEA with LEM and TACE in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial summary
The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TEA with LEM and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesHong Kong
- Study dates
- Jun 2007to Nov 2014
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient factor
- Age > 18
- Child-Pugh A or B cirrhosis
- ECOG performance status Grade 2 or below
- No serious concurrent medical illness
- No prior treatment (including surgery) for HCC
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- Tumor factor
- Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
- Unresectable and locally advanced disease without extra-hepatic disease
- Massive expansive or nodular tumor morphology with measurable lesion on CT
- Size of largest tumor <= 15cm in largest dimension
- Number of main tumor <= 5, excluding associated small satellite lesions.
Who cannot join
- Patient factor
- History of prior malignancy except skin cancer
- History of significant concurrent medical illness such as ischemic heart disease or heart failure
- History of acute tumor rupture
- Serum creatinine level > 180 umol/L
- Presence of biliary obstruction not amenable to percutaneous drainage
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- Child-Pugh C cirrhosis
- Evidence of poor liver function
- History of hepatic encephalopathy, or
- Intractable ascites not controllable by medical therapy, or
- History of variceal bleeding within last 3 months, or
- Serum total bilirubin level > 50 umol/L, or
- Serum albumin level < 28g/L, or
- INR > 1.3
- Tumor factor
- Presence of extrahepatic metastasis
- Predominantly infiltrative lesion
- Diffuse tumor morphology with extensive lesions involving both lobes.
- Vascular complications
- Hepatic artery thrombosis, or
- Partial or complete thrombosis of the main portal vein, or
- Tumor invasion of portal branch of contralateral lobe, or
- Hepatic vein tumor thrombus, or
- Significant arterioportal shunt not amenable to shunt blockage, or
- Significant arteriovenous shunt not amenable to shunt blockage
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma
The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.
Read the detailed description
The standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (TACE). However, The drawback of conventional chemoembolization (TACE) for liver cancer is that it cannot effectively embolize portal venules supplying the tumors, therefore chemoembolization is difficult to completely eradicate the tumor. Usually multiple treatments are required and tumor recurrences are common.
Transarterial Ethanol Ablation (LEM) can potentially provide a better treatment outcome with fewer treatment sessions. Preliminary results from a clinical study showed that the complication rate is reduced while survival rate may be improved. This study aims to compare survival duration and response rate between the treatments TACE and LEM.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TEA with LEM, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEA with LEMProcedure or surgery
Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)
TACEProcedure or surgery
Transarterial chemoembolisation (TACE)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TEA with LEM Receives: Procedure: TEA with LEM |
| 2 | Active comparator | TACE Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
progression free survival
Measured: 3 years
Secondary outcomes (5)
tumor response
Measured: 4 weeks after end of treatment
rate of conversion to resectable stage
Measured: 4 weeks after end of treatment
toxicity of treatment
Measured: 4 weeks after end of treatment
quality of life
Measured: up to one year after randomisation
consumption of hospital resources
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin P Hui, Chinese University of Hong Kong
- Investigators
- Simon CH Yu, MD, FRCR, Principal investigator, Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467974
- Sponsor's protocol ID
- HCC017
- Status last verified
- Dec 2014
- First submitted
- 30 Apr 2007
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu SC, Hui JW, Hui EP, Chan SL, Lee KF, Mo F, Wong J, Ma B, Lai P, Mok T, Yeo W. Unresectable hepatocellular carcinoma: randomized controlled trial of transarterial ethanol ablation versus transcatheter arterial chemoembolization. Radiology. 2014 Feb;270(2):607-20. doi: 10.1148/radiol.13130498. Epub 2013 Oct 28.
PubMed 24126369
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00467974
- Acronym / sponsor ID
- HCC017
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 May 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.
The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.
Detailed description
The standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (TACE). However, The drawback of conventional chemoembolization (TACE) for liver cancer is that it cannot effectively embolize portal venules supplying the tumors, therefore chemoembolization is difficult to completely eradicate the tumor. Usually multiple treatments are required and tumor recurrences are common.
Transarterial Ethanol Ablation (LEM) can potentially provide a better treatment outcome with fewer treatment sessions. Preliminary results from a clinical study showed that the complication rate is reduced while survival rate may be improved. This study aims to compare survival duration and response rate between the treatments TACE and LEM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: TEA with LEMTEA with LEM |
| 2 | Active comparator | Procedure: TACETACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient factor
- Age > 18
- Child-Pugh A or B cirrhosis
- ECOG performance status Grade 2 or below
- No serious concurrent medical illness
Key exclusion criteria (25 listed)
- Patient factor
- History of prior malignancy except skin cancer
- History of significant concurrent medical illness such as ischemic heart disease or heart failure
- History of acute tumor rupture
- Serum creatinine level > 180 umol/L
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 |
|---|---|---|
| TEA with LEMTransarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM) | Procedure or surgery | 1 |
| TACETransarterial chemoembolisation (TACE) | Procedure or surgery | 2 |
Primary outcome
overall survival
Time frame: 3 years
progression free survival
Time frame: 3 years
5 secondary outcomes
tumor response
Time frame: 4 weeks after end of treatment
rate of conversion to resectable stage
Time frame: 4 weeks after end of treatment
toxicity of treatment
Time frame: 4 weeks after end of treatment
quality of life
Time frame: up to one year after randomisation
consumption of hospital resources
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Derived from this study: PubMed 24126369Yu SC, Hui JW, Hui EP, Chan SL, Lee KF, Mo F, Wong J, Ma B, Lai P, Mok T, Yeo W. Unresectable hepatocellular carcinoma: randomized controlled trial of transarterial ethanol ablation versus transcatheter arterial chemoembolization. Radiology. 2014 Feb;270(2):607-20. doi: 10.1148/radiol.13130498. Epub 2013 Oct 28.
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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.
Simon CH Yu, MD, FRCR principal investigator
Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TEA with LEM and TACE in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
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 12 inclusion and 25 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: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00467974, which also lists 1 linked publication.
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 26 Jan 2015.