Unresectable Hepatocellular CarcinomaPhase 1/2NCT03107416
Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
A Phase 1/2 study testing Hepatic artery embolization (HAE) and Bumetanide in people with Unresectable Hepatocellular Carcinoma, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.
Trial summary
The purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Hepatic artery embolization (HAE) and Bumetanide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Apr 2017to 5 Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1). Regional lymphadenopathy will be allowed.
- Any virus status accepted (e.g. Hepatitis C etc.)
- Any prior liver treatment
- Patients within unresectable HCC
- At least 18 years old
- ECOG performance status 0 or 1
- Radiographically measurable disease per mRECIST 1.1
- Meets standard of care to undergo embolization
Who cannot join
- Women who are pregnant or lactating
- Documented hypersensitivity to bumetanide or sulfonamides
- Patients with resectable HCC
- High risk for post-embolization hepatic failure:
- °Child's C cirrhosis
- °> 80% liver involvement by tumor
Show all 14Show fewer
- Contraindication to angiography/embolization including:
- Patients cannot receive contrast:
- Severe allergic reaction to contrast despite premedication
- Poor renal function not on dialysis
- Other, based on judgment of the investigator
- ECOG score 2
- Main portal vein tumor thrombus
- BCLC D = patients with distant metastasis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and follow-up only)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
The purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Hepatic artery embolization (HAE), Bumetanide
- Keywords
- Bumetanide, Diuretic, Transarterial Embolization (TAE), 17-141
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic artery embolization (HAE)Procedure or surgery
The intervention being studied is HAE for the treatment of HCC in combination with Bumetanide. HAE is a standard of care procedure.
BumetanideDrug
Intra-arterial (IA) injection of 0.01mg/kg of Bumetanide in the first cohort, 0.02 mg/kg in the second cohort and 0.04 mg/kg of IA Bumetanide in the final cohort patients during standard HAE until stasis is evident.
| Study group | Role | What they receive |
|---|---|---|
| Bumetanide | Experimental | Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level. Receives: Procedure: Hepatic artery embolization (HAE); Drug: Bumetanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) (phase I)
Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level.
Measured: 1 year
estimate the local tumor progression (LTP) rates (phase II)
After the last first stage patient has three months followup, 6-month LTP will be estimated using Kaplan-Meier methods. If the one-sided 90% lower confidence bound is less than 40% the study will stop. Otherwise 12 more patients will be enrolled for a total of 30. At the end of the study 12-month LTP will be estimated using competing risk (cumulative incidence) methods.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start5 Apr 2017
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hooman Yarmohammadi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107416
- Sponsor's protocol ID
- 17-141
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2017
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03107416
- Acronym / sponsor ID
- 17-141
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Bumetanide, Diuretic, Transarterial Embolization (TAE), 17-141
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 11 Apr 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 purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bumetanide | Experimental | Procedure: Hepatic artery embolization (HAE), Drug: BumetanideThree escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1). Regional lymphadenopathy will be allowed.
- Patients within unresectable HCC
- At least 18 years old
- ECOG performance status 0 or 1
- Radiographically measurable disease per mRECIST 1.1
Key exclusion criteria (14 listed)
- Women who are pregnant or lactating
- Documented hypersensitivity to bumetanide or sulfonamides
- Patients with resectable HCC
- High risk for post-embolization hepatic failure:
- °Child's C cirrhosis
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 |
|---|---|---|
| Hepatic artery embolization (HAE)The intervention being studied is HAE for the treatment of HCC in combination with Bumetanide. HAE is a standard of care procedure. | Procedure or surgery | Bumetanide |
| BumetanideIntra-arterial (IA) injection of 0.01mg/kg of Bumetanide in the first cohort, 0.02 mg/kg in the second cohort and 0.04 mg/kg of IA Bumetanide in the final cohort patients during standard HAE until stasis is evident. | Drug | Bumetanide |
Primary outcome
Maximum tolerated dose (MTD) (phase I)
Time frame: 1 year
Three escalating doses of bumetanide will be used: 0.01 mg/kg (level 1), 0.02 mg/kg (level 2) and 0.04 mg/kg (level 3) in a standard 3+3 design. Starting with level 1, three patients will first be enrolled at each level.
estimate the local tumor progression (LTP) rates (phase II)
Time frame: 1 year
After the last first stage patient has three months followup, 6-month LTP will be estimated using Kaplan-Meier methods. If the one-sided 90% lower confidence bound is less than 40% the study will stop. Otherwise 12 more patients will be enrolled for a total of 30. At the end of the study 12-month LTP will be estimated using competing risk (cumulative incidence) methods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Hooman Yarmohammadi, MD principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hepatic artery embolization (HAE) and Bumetanide in people with Unresectable Hepatocellular Carcinoma, run by Memorial Sloan Kettering Cancer Center at 5 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Maximum tolerated dose (MTD) (phase I) (time frame: 1 year). 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?
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 5 May 2026.