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Clinical Trials in Switzerland / NCT07302919
Recruiting Phase 2/3

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

NCT07302919 · tracked via the Priya Life Science Switzerland tracker
Phase
Phase 2/3
Started
2026-02-16
Last updated
2026-03-02

Condition(s) studied

Hepato Cellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

DEB-DoxNic-TACEcurrent standard of care

DEB-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)

current standard of care: TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Informed consent as documented by signature, * Age ≥18 years, * Diagnosis of HCC by biopsy or by established imaging criteria using CT or MRI, * At least one target lesion without prior treatment, * Diameter of the target lesion ≥3 cm and ≤8 cm, * Preserved liver function (no jaundice, no ascites, no overt hepatic encephalopathy). * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods for at least 3 months after the TACE treatment. Exclusion Criteria: * Any prior systemic therapy for advanced HCC, * Diffuse tumor lesions, extrahepatic metastases, or vascular invasion, * Hepatic encephalopathy, * Uncontrolled ascites or pleural effusion, * Jaundice, * Severe hypotension or hemodynamic shock or need of vasoactive medications, * Decompensated heart failure New York Heart Association (NYHA) class IV, * eGFR \< 15 mL/min/1.73 m2 per MDRD (Modification of Diet in Renal Disease) formula, * Myocardial infarction within the last 6 months, * Life expectancy \<12 weeks, * Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to calcium antagonists, * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant, * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 3 months after the TACE treatment.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
University Hospital Basel Basel Switzerland Recruiting
Hôpitaux Universitaires de Genève Geneva Switzerland Recruiting
Kantonsspital St. Gallen Sankt Gallen Switzerland Recruiting

More University Hospital, Basel, Switzerland trials in Switzerland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07302919 on ClinicalTrials.gov ↗ ← All trials in Switzerland