Hepatocellular CarcinomaPhase 1NCT03259581
Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
A Phase 1 study testing Transarterial chemoembolization in people with Hepatocellular Carcinoma and Bilirubinemia, run by University of Minnesota at 1 site in United States.
Trial summary
The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Bilirubinemia
- What is being tested?
- Transarterial chemoembolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 1 Feb 2022
- Phase
- Phase 1
- 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
- hepatocellular carcinoma (HCC)
- Direct or conjugated bilirubin < 3 mg/dl
- Total bilirubin > 3 mg/dl
- Willing and able to provide informed consent
- >18 years of age
Who cannot join
- Currently pregnant
- Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
- Arterial anatomy which would preclude selective transarterial chemoembolization
- Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
- Patients with extrahepatic metastases
- Patients with portal vein invasion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.
- Conditions
- Hepatocellular Carcinoma, Bilirubinemia
- Being tested
- Transarterial chemoembolization
- Keywords
- transarterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolizationCombination product
Delivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles.
| Study group | Role | What they receive |
|---|---|---|
| Transarterial chemoembolization | Experimental | Transarterial chemoembolization Receives: Combination Product: Transarterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure related adverse events
Percentage of adverse events following TACE
Measured: 1 month
Secondary outcomes (5)
Radiologic Response
mRECIST response after TACE
Measured: 1 month
Progression free survival
Liver PFS and overall PFS
Measured: 1, 3, 6, 12, 18, and 24 months
Overall survival
Overall survival
Measured: 24 months
Change in Model for end stage liver disease (MELD)
Change in MELD (MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43) score at 7 and 30 days post TACE
Measured: 7 and 30 days
Change in Child Pugh score
Change in Child Pugh score at 7 and 30 days post TACE
Measured: 7 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start2 Jan 2018
- Primary completion31 Dec 2021
- Study completion1 Feb 2022
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 University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259581
- Sponsor's protocol ID
- 2016LS137
- Status last verified
- Mar 2022
- First submitted
- 1 Aug 2017
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
- ClinicalTrials.gov ID
- NCT03259581
- Acronym / sponsor ID
- 2016LS137
- Conditions
- Hepatocellular Carcinoma, Bilirubinemia
- Keywords
- transarterial chemoembolization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 23 Aug 2017 (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.
The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transarterial chemoembolization | Experimental | Combination Product: Transarterial chemoembolizationTransarterial chemoembolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hepatocellular carcinoma (HCC)
- Direct or conjugated bilirubin < 3 mg/dl
- Total bilirubin > 3 mg/dl
- Willing and able to provide informed consent
- >18 years of age
Key exclusion criteria (6 listed)
- Currently pregnant
- Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
- Arterial anatomy which would preclude selective transarterial chemoembolization
- Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
- Patients with extrahepatic metastases
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 chemoembolizationDelivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles. | Combination product | Transarterial chemoembolization |
Primary outcome
Procedure related adverse events
Time frame: 1 month
Percentage of adverse events following TACE
5 secondary outcomes
Radiologic Response
Time frame: 1 month
Progression free survival
Time frame: 1, 3, 6, 12, 18, and 24 months
Overall survival
Time frame: 24 months
Change in Model for end stage liver disease (MELD)
Time frame: 7 and 30 days
Change in Child Pugh score
Time frame: 7 and 30 days
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 21 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transarterial chemoembolization in people with Hepatocellular Carcinoma and Bilirubinemia, run by University of Minnesota at 1 site in United States.
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 5 inclusion and 6 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 21 Mar 2022. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Procedure related adverse events (time frame: 1 month). 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 21 Mar 2022.