Diuretic + Arterial Embolization for Liver Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Child's C cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Diuretic + Arterial Embolization for Liver Cancer?

Research shows that hepatic artery embolization (HAE) can lead to subjective improvement in 73.9% and objective improvement in 65.2% of patients with inoperable liver tumors, indicating its potential effectiveness in treating liver cancer. ^{1 2 3 4 5}

Is the combination of diuretics and hepatic artery embolization safe for treating liver cancer?

Hepatic artery embolization (HAE) has been used in patients with liver tumors, and studies show it generally has low treatment-related complications. In one study, no adverse effects were observed during surgery, and another reported a low mortality rate of 4.2% after HAE. However, some animal studies indicated potential liver damage, suggesting more research is needed before clinical use. ^{1 2 4 6 7}

How is the treatment 'Diuretic + Arterial Embolization for Liver Cancer' different from other treatments for liver cancer?

This treatment is unique because it combines hepatic artery embolization (HAE), which blocks blood flow to liver tumors, with a diuretic, potentially enhancing the treatment's effectiveness. HAE is typically used for inoperable liver cancers and can improve symptoms and survival, but the addition of a diuretic is a novel approach that may offer additional benefits. ^{1 3 4 6 8}

What is the purpose of this trial?

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.

Research Team

Hooman Yarmohammadi, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

I have been diagnosed with liver cancer following EASL guidelines.

I have had treatment for my liver before.

Exclusion Criteria

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

My liver cancer can be surgically removed.

I cannot undergo angiography/embolization due to health issues like severe allergies or poor kidney function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of Bumetanide during transarterial hepatic embolization

1 year

Follow-up

Participants are monitored for local tumor progression and safety after treatment

6 months

Treatment Details

Interventions

• Bumetanide
• Hepatic Artery Embolization (HAE)

Trial Overview 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.

Participant Groups

Group I: Bumetanide Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Embolization of the hepatic artery in the treatment of malignant tumors of the liver]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Prospective randomized controlled trial of hepatic arterial embolization or infusion chemotherapy with 5-fluorouracil and degradable starch microspheres for colorectal liver metastases. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Hepatobiliary imaging of functional and morphological changes following hepatic arterial embolization in hepatocellular carcinoma. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Prolonged survival after hepatic artery embolization in patients with midgut carcinoid syndrome. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

A comparison of outcomes from treating hepatocellular carcinoma by hepatic artery embolization in patients younger or older than 70 years. [2017]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The preoperative embolization of the hepatic artery in patients with malignant liver tumors]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Hepatic artery embolization of experimental hepatic tumors with absolute ethanol. [2019]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[X-ray endovascular embolization of the hepatic artery in the palliative treatment of hepatocellular cancer]. [2016]