NCT07302919Recruiting
Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2 · Phase 3
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University Hospital, Basel, Switzerland(Other)
- Protocol no.
- 2024-02072, bb24heim
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Interventions
- Combination product
Treatments studied
- DEB-DoxNic-TACE
- current standard of care
Locations · 3
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Geneva, SwitzerlandHôpitaux Universitaires de GenèveRecruiting at this site
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
In total, worldwide, all 3 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: March 2, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.