Hepatocellular CarcinomaPhase 3NCT02004210
A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma
A Phase 3 study testing transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- transarterial radioembolization (TARE) and transarterial chemoembolization (TACE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Apr 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
- Patients with single large HCC or multinodular HCC
- Single \& 5cm < size < 15cm
- 2-5 nodules \& maximal sized 4-15cm \& sum of diameters ≦ 25cm
- Infiltrative type \& unilobular involvement on liver MRI
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- Segmental or lobar portal vein invasion can be included.
- Age : 20 years to 80 years
- ECOG Performance Status of 0 to 2
- Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
- Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- WBC count ≧ 1,000/mm3
- Absolute neutrophil count > 500/mm3
- Hb ≧ 7.0 g/dL
- Platelet count > 100,000 /mm3
- Bilirubin ≦ 3 mg/dL
- Adequate clotting function: INR ≦ 2.3 or ≦ 6sec
Who cannot join
- Child-Pugh score ≧ 8
- ECOG Performance Status ≧ 3
- Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
- History of organ allograft
- Patients with uncontrolled co-morbidity which needs treatment
- Patients who have received prior systemic chemotherapy
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- Patients who have received Capecitabine within 8 weeks
- Patients with extrahepatic metastasis
- Main portal vein invasion
- Patients with lymph node metastasis
- Bilobar involvement
- Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
Read the detailed description
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.
However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- transarterial radioembolization (TARE), transarterial chemoembolization (TACE)
- Keywords
- transarterial chemoembolization, transarterial radioembolization, advanced 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.
transarterial radioembolization (TARE)Procedure or surgery
transarterial radioembolization
transarterial chemoembolization (TACE)Procedure or surgery
transarterial chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| The TARE group | Experimental | transarterial radioembolization group Receives: Procedure: transarterial radioembolization (TARE) |
| The TACE group | Experimental | Transarterial chemoembolization group Receives: Procedure: transarterial chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From date of randomization until the date of death
Measured: every 12 weeks, up to the time of death, up to 12 months
Secondary outcomes (3)
Progression-Free Survival in the Liver
From date of randomization until the date of first documented intrahepatic tumor progression or death
Measured: every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
Progression-Free Survival Overall
From date of randomization until the date of first documented progression or death
Measured: every 12 weeks, up to the time of death or first documented progression, up to 12 months
Overall tumor response assessment
(CR, PR, SD, PD)by modified RECIST criteria
Measured: every 12 weeks, up to the time of death or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: No participants were enrolled.
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.
- More trials run by Seoul National University HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- Jung-Hwan Yoon, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004210
- Sponsor's protocol ID
- TACE_TARE
- Status last verified
- Apr 2016
- First submitted
- 1 Oct 2013
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02004210
- Acronym / sponsor ID
- TACE_TARE
- Conditions
- Hepatocellular Carcinoma
- Keywords
- transarterial chemoembolization, transarterial radioembolization, advanced hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 9 Dec 2013 (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 is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
Detailed description
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.
However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.
The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The TARE group | Experimental | Procedure: transarterial radioembolization (TARE)transarterial radioembolization group |
| The TACE group | Experimental | Procedure: transarterial chemoembolization (TACE)Transarterial chemoembolization group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
- Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
- Patients with single large HCC or multinodular HCC
- Age : 20 years to 80 years
- ECOG Performance Status of 0 to 2
Key exclusion criteria (13 listed)
- Child-Pugh score ≧ 8
- ECOG Performance Status ≧ 3
- Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
- History of organ allograft
- Patients with uncontrolled co-morbidity which needs treatment
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 |
|---|---|---|
| transarterial radioembolization (TARE)transarterial radioembolization | Procedure or surgery | The TARE group |
| transarterial chemoembolization (TACE)transarterial chemoembolization | Procedure or surgery | The TACE group |
Primary outcome
Overall survival
Time frame: every 12 weeks, up to the time of death, up to 12 months
From date of randomization until the date of death
3 secondary outcomes
Progression-Free Survival in the Liver
Time frame: every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
Progression-Free Survival Overall
Time frame: every 12 weeks, up to the time of death or first documented progression, up to 12 months
Overall tumor response assessment
Time frame: every 12 weeks, up to the time of death or 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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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.
Jung-Hwan Yoon, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site 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 17 inclusion and 13 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: withdrawn, as of the sponsor's last update on 27 Apr 2016. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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: every 12 weeks, up to the time of death, up to 12 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 27 Apr 2016.