Clinical trial · Interventional
Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells
Phase I/II Study of Transarterial Hepatic Embolization With Bumetanide in Unresectable Hepatocellular Carcinoma
NCT03107416CI-TRIAL-00110469active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bumetanide | Drug | — | UNRESOLVED |
| Hepatic artery embolization (HAE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bumetanide
- description
- 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.
- interventionNames
- Procedure: Hepatic artery embolization (HAE)
- Drug: Bumetanide
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) (phase I)
- timeFrame
- 1 year
- description
- 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.
- measure
- estimate the local tumor progression (LTP) rates (phase II)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.