Hepatocellular CarcinomaNCT01677468
Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma
A study testing Intermediate embolization and Complete embolization in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Hallym University Medical Center at 3 sites in South Korea.
Trial summary
The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Transarterial Chemoembolization
- What is being tested?
- Intermediate embolization and Complete embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Aug 2012to Jul 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18
- ECOG performance status 0-2
- Hepatocellular carcinoma diagnosed histologically or clinically
- Tumor numbers of 5 or less
- No history of treatment for hepatocellular carcinoma
- Patients with informed consent
Who cannot join
- Extrahepatic metastasis
- Rupture of hepatocellular carcinoma
- Infiltrative hepatocellular carcinoma
- Malignancy other than hepatocellular carcinoma
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Hallym Sacred Heart Hospital
Anyang, 431070
Choong Kee Park, M.D., Ph.D., 82-31-380-3708, ckp@hallym.or.kr
- Recruiting
Chuncheon Sacred Heart Hospital
Chuncheon, 200060
Dong Joon Kim, M.D., Ph.D., 82-33-741-1226, djkim@hallym.ac.kr
- Recruiting
Kangnam Sacred Heart Hostpita
Seoul, 150950
Sang Hoon Park, M.D., Ph.D., 82-2-829-5493, dr.sanghoon.park@gmail.com
Sang Hoon Park, M.D., Ph.D
About this study
Official title: Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma
The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
Read the detailed description
Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
- Being tested
- Intermediate embolization, Complete embolization
- Keywords
- Hepatocellular carcinoma, Transarterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermediate embolizationProcedure or surgery
Also called Adriamycin, Cysplatin, Gelfoam
TACE with substasis using gelfoam
Complete embolizationProcedure or surgery
Also called Adriamycin, Cysplatin, Gelfoam
TACE with complete embolization using gelfoam
| Study group | Role | What they receive |
|---|---|---|
| Intermediate embolization | Experimental | TACE with substatsis using gelfoam Receives: Procedure: Intermediate embolization |
| Complete embolization | Active comparator | TACE with complete embolization using gelfoam Receives: Procedure: Complete embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the subjects
Survival rate of the subjects 6 months after TACE
Measured: 6 months after TACE
Survival rate of the subjects
Survival rate of the subjects, 12 months after TACE
Measured: 12 months after TACE
Survival rate of the subjects
Survival rate of the subjects, 18 months after TACE
Measured: 18 months after TACE
Survival rate of the subjects
Survival rate of the subjects, 24 months after TACE
Measured: 24 months after TACE
Secondary outcomes (2)
Disease free survival of the subjects
Disease free survival of the subjects, 24 months after TACE
Measured: 6, 12, 18, and 24 months after TACE
Complication rate of TACE
The incidence of infection, hemorrhage, 24 months after TACE
Measured: 6, 12, 18, and 24 months after TACE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang Hoon Park, M.D., Ph.D., Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677468
- Sponsor's protocol ID
- 2011-12-122
- Status last verified
- Aug 2012
- First submitted
- 9 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01677468
- Acronym / sponsor ID
- 2011-12-122
- Keywords
- Hepatocellular carcinoma, Transarterial chemoembolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 3 Sep 2012 (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 aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
Detailed description
Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate embolization | Experimental | Procedure: Intermediate embolizationTACE with substatsis using gelfoam |
| Complete embolization | Active comparator | Procedure: Complete embolizationTACE with complete embolization using gelfoam |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age over 18
- ECOG performance status 0-2
- Hepatocellular carcinoma diagnosed histologically or clinically
- Tumor numbers of 5 or less
- No history of treatment for hepatocellular carcinoma
Key exclusion criteria (4 listed)
- Extrahepatic metastasis
- Rupture of hepatocellular carcinoma
- Infiltrative hepatocellular carcinoma
- Malignancy other than hepatocellular carcinoma
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 |
|---|---|---|
| Intermediate embolizationAlso: Adriamycin, Cysplatin, GelfoamTACE with substasis using gelfoam | Procedure or surgery | Intermediate embolization |
| Complete embolizationAlso: Adriamycin, Cysplatin, GelfoamTACE with complete embolization using gelfoam | Procedure or surgery | Complete embolization |
Primary outcome
Survival rate of the subjects
Time frame: 6 months after TACE
Survival rate of the subjects 6 months after TACE
Survival rate of the subjects
Time frame: 12 months after TACE
Survival rate of the subjects, 12 months after TACE
Survival rate of the subjects
Time frame: 18 months after TACE
Survival rate of the subjects, 18 months after TACE
Survival rate of the subjects
Time frame: 24 months after TACE
Survival rate of the subjects, 24 months after TACE
2 secondary outcomes
Disease free survival of the subjects
Time frame: 6, 12, 18, and 24 months after TACE
Complication rate of TACE
Time frame: 6, 12, 18, and 24 months after TACE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
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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.
Sang Hoon Park, M.D., Ph.D. principal investigator
Hallym University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermediate embolization and Complete embolization in people with Hepatocellular Carcinoma and Transarterial Chemoembolization, run by Hallym University Medical Center at 3 sites in South Korea.
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 6 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 3 Sep 2012. 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 South Korea. 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 Sang Hoon Park, M.D., Ph.D. (82-2-829-5493, dr.sanghoon.park@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of the subjects (time frame: 6 months after TACE). The study lists 4 primary outcomes in all. 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 3 Sep 2012.