TACE with doxorubicin plus ABCB1 blocker nicardipine versus standard TACE for liver cancer
Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
This trial tests whether adding the ABCB1 blocker nicardipine to doxorubicin-based TACE helps people with hepatocellular carcinoma (tumors 3–8 cm) get better tumor control than standard TACE alone.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | doxorubicin, chemotherapy |
| Locations | 3 sites (Basel and 2 other locations) |
| Trial ID | NCT07302919 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with HCC who have at least one untreated tumor 3–8 cm in size, preserved liver function, no extrahepatic disease or vascular invasion, and no prior systemic HCC therapy.
Not a fit: Patients with diffuse lesions, extrahepatic metastases, vascular invasion, decompensated liver disease, severe cardiac or renal dysfunction, or prior systemic HCC therapy are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding nicardipine could raise the rate of complete tumor kill after TACE and delay progression or the need for additional therapies.
How similar studies have performed: Preclinical work and limited clinical reports indicate ABCB1 inhibition can enhance doxorubicin activity, but large randomized Phase 2/3 evidence in the TACE setting is currently limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.