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NCT Number: NCT03107416

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Unresectable Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatic artery embolization (HAE)

Procedure

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

Bumetanide

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2017
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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