RecruitingPhase 2Phase 3NCT07302919

Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma

Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE


Sponsor

University Hospital, Basel, Switzerland

Enrollment

152 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

IMPACT-TACE is an investigator-initiated, prospective, multicenter, randomized, double-blinded, interventional trial to test the hypothesis that the simultaneous application of doxorubicin with the ABCB1 inhibitor nicardipine would significantly improve the success rate of TACE treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug that blocks a protein called ABCB1 (a pump that can make liver cancer cells resistant to treatment) to a standard procedure called TACE (transarterial chemoembolization) can improve outcomes for patients with liver cancer. TACE delivers chemotherapy directly into the blood vessels feeding the tumor. **You may be eligible if...** - You are 18 or older - You have been diagnosed with hepatocellular carcinoma (the most common type of liver cancer), confirmed by biopsy or imaging - You have at least one tumor that has not been previously treated, measuring between 3 and 8 cm - Your liver function is reasonably preserved (no jaundice, fluid buildup, or confusion from liver failure) **You may NOT be eligible if...** - Your liver function is severely impaired - Your tumor has already been treated or is outside the size range - You have other serious health conditions, including advanced heart or kidney disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDEB-DoxNic-TACE

TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads (DEB) loaded with 33mg/ml doxorubicin (Dox) and 0.3mg/mL nicardipine (Nic)

COMBINATION_PRODUCTcurrent standard of care

TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin


Locations(3)

University Hospital Basel

Basel, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07302919


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