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Diuretic + Arterial Embolization for Liver Cancer

Phase 1 & 2

Waitlist Available

Led By Hooman Yarmohammadi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets standard of care to undergo embolization

Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1) with regional lymphadenopathy allowed

Must not have

High risk for post-embolization hepatic failure: Child's C cirrhosis, > 80% liver involvement by tumor

Patients with resectable HCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of a medication, Bumetanide, to see if it has any effect on people who regularly undergo tumor TAE (a medical procedure).

Who is the study for?

This trial is for adults with inoperable liver cancer, regardless of viral status. They must have a good performance status (able to carry out daily activities), measurable disease by specific criteria, and be eligible for embolization treatment. People can't join if they're pregnant or breastfeeding, allergic to bumetanide/sulfonamides, have resectable cancer, poor kidney function not on dialysis, certain blood vessel blockages or advanced cirrhosis.

What is being tested?

The study tests the safety of different doses of Bumetanide when delivered directly into the liver artery followed by plugging up the artery—a procedure known as Hepatic Artery Embolization—to treat liver cancer. The goal is to see how this approach affects patients who are already getting tumor embolization as part of their standard care.

What are the potential side effects?

Bumetanide may cause dehydration due to increased urination; it could also lead to electrolyte imbalances like low potassium levels. There might be local reactions at the infusion site or more general side effects such as dizziness or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a procedure to block blood flow to cancer cells.

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I have been diagnosed with liver cancer following EASL guidelines.

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I have had treatment for my liver before.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My liver cancer cannot be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at high risk for liver failure after a specific liver procedure due to severe liver disease or extensive liver tumor.

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My liver cancer can be surgically removed.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD) (phase I)

estimate the local tumor progression (LTP) rates (phase II)

Side effects data

From 2019 Phase 2 trial • 34 Patients • NCT03923933

69%

Creatinine Increase

25%

hyperuricemia

13%

Hyponatremia

13%

hypokalemia

Major adverse cardiovascular events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Treatment Grup

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BumetanideExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bumetanide

2010

Completed Phase 2

~260

0 / 9Eligibility criteria met