TACE with doxorubicin plus ABCB1 blocker nicardipine versus standard TACE for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

IMPACT-TACE is a multicenter, randomized, double-blind Phase 2/3 trial comparing drug-eluting bead TACE loaded with doxorubicin plus the ABCB1 inhibitor nicardipine to standard TACE alone. Eligible patients have at least one untreated HCC lesion between 3 and 8 cm and preserved liver function, and are randomized to receive DEB-DoxNic-TACE or current standard of care. The trial tests whether blocking ABCB1-mediated drug resistance increases complete tumor necrosis and improves clinical outcomes such as progression-free and overall survival. Procedures, safety monitoring, and imaging follow-up are standardized across Swiss university hospital sites to compare efficacy and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Fahim Ebrahimi, PD Dr.
• Email: fahim.ebrahimi@clarunis.ch
• Phone: +41 61 777 74 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.