Hepatocellular Carcinoma Non-resectableNCT03533920
Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
A study testing UNI-DEB in people with Hepatocellular Carcinoma Non-resectable, run by Jeil Pharmaceutical Co., Ltd. at 8 sites in South Korea.
Trial summary
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- UNI-DEB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 25 Oct 2017to 3 Sep 2018
- 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
- Over 19 years
- Diagnosis of HCC
- Unresectable asymtomatic uninodular or multinodular tumor.
- Subject who maintain clinically normal hepatopetal flow without main portal vein closure
- At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less.
- ECOG Performance Status of 0 or 1.
- Child-Pugh class A or B
- Life expectancy of at least 6 months.
Who cannot join
- Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
- Hepatic resection, liver transplantation or Percutaneous local treatment
- Previously received HCC related medical procedure
- Previously treated with anthracyclines
- Only measurable disease is within an area of the liver previously subjected to radiotherapy.
- Child Pugh C
Show all 14Show fewer
- Active gastrointestinal bleeding within 6 months from screening.
- Total bilirubin > 3mg/dL
- WBC < 3,000cells/mm3
- Platelet < 50,000mm3
- Serum creatinine > 2mg/dL
- INR> 1.4
- ALT and AST > 5 times UNL
- Diffuse HCC defined as >50% tumour involvement of the whole liver.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Chonnam National University Hospital
Gwangju
Seoul National University Bundang Hospital
Gyeonggi-do
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Gyeonggi-do
Inha University Hospital
Incheon
Pusan National University Hospital
Pusan
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
About this study
Official title: A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- UNI-DEB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNI-DEBDevice
Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient
| Study group | Role | What they receive |
|---|---|---|
| UNI-DEB | Experimental | Not described Receives: Device: UNI-DEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate by independent evaluator
Measured: 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start25 Oct 2017
- Primary completion30 Jun 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533920
- Sponsor's protocol ID
- UNI-DEB-Pivotal
- Status last verified
- Sep 2018
- First submitted
- 11 May 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, Open, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03533920
- Acronym / sponsor ID
- UNI-DEB-Pivotal
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 23 May 2018 (actual)
- 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.
Pivotal Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UNI-DEB | Experimental | Device: UNI-DEB |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 19 years
- Diagnosis of HCC
- Unresectable asymtomatic uninodular or multinodular tumor.
- Subject who maintain clinically normal hepatopetal flow without main portal vein closure
- At least one measurable target lesion by CT or MRI which 10 mm or more and 100 mm or less.
Key exclusion criteria (14 listed)
- Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
- Hepatic resection, liver transplantation or Percutaneous local treatment
- Previously received HCC related medical procedure
- Previously treated with anthracyclines
- Only measurable disease is within an area of the liver previously subjected to radiotherapy.
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 |
|---|---|---|
| UNI-DEBApplicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient | Device | UNI-DEB |
Primary outcome
Objective Response Rate by independent evaluator
Time frame: 4 weeks after treatment
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 1 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNI-DEB in people with Hepatocellular Carcinoma Non-resectable, run by Jeil Pharmaceutical Co., Ltd. at 8 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 8 inclusion and 14 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 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
Objective Response Rate by independent evaluator (time frame: 4 weeks after treatment). 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 1 Oct 2018.