Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Live… (NCT03107416) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
United States30 participantsStarted 2017-04-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) (phase I)
Timeframe: 1 year
2
estimate the local tumor progression (LTP) rates (phase II)