Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2026-04-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Unresectable Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bumetanide

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.

Group Type EXPERIMENTAL

Hepatic artery embolization (HAE)

Intervention Type PROCEDURE

The intervention being studied is HAE for the treatment of HCC in combination with Bumetanide. HAE is a standard of care procedure.

Bumetanide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type PROCEDURE

Bumetanide

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No