Adding nicardipine to chemoembolization for liver cancer
Tests adding nicardipine to doxorubicin chemoembolization in adults with hepatocellular carcinoma.
Plain-language title generated from the registry record
Registry title: Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
Key facts
- Where
- Basel, Geneva, and Sankt Gallen, SwitzerlandSee the 3 sites
- Phase
- Phase 2/3
Where in Switzerland
- University Hospital BaselBasel, SwitzerlandTaking people
- Hôpitaux universitaires de GenèveGeneva, SwitzerlandTaking people
- Kantonsspital St. GallenSankt Gallen, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Basel, Switzerland
- Trial code
- NCT07302919
- Record updated
- 2 March 2026
- Original description
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.Read full original descriptionShow less
Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
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: 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: Any prior systemic therapy for advanced HCC,; Severe hypotension or hemodynamic shock or need of vasoactive medications,; Decompensated heart failure New York Heart Association (NYHA) class IV,; Myocardial infarction within the last 6 months,; Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,; eGFR < 15 mL/min/1.73 m2 per MDRD (Modification of Diet in Renal Disease) formula,; Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to calcium antagonists,; Diffuse tumor lesions, extrahepatic metastases, or vascular invasion,; Hepatic encephalopathy,; Uncontrolled ascites or pleural effusion,; Jaundice,; Life expectancy <12 weeks,; Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 3 months after the TACE treatment.