Adding nicardipine to chemoembolization for liver cancer
Tests adding nicardipine to doxorubicin chemoembolization in adults with hepatocellular carcinoma.
Key facts
- Who runs it
- University Hospital, Basel, Switzerland
- Where
- Basel, Geneva, and Sankt Gallen, SwitzerlandSee the 3 sites
- Trial code
- Registry title
- Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 152 people, planned
- Started
- 16 Feb 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- DEB-DoxNic-TACE
- current standard of care
- Record updated
- 2 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cancer (hepatocellular carcinoma) who have a tumour not treated before and still have good liver function.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Hepatocellular carcinoma shown by biopsy or by CT or MRI scan. At least one untreated target tumour, 3 cm (1.2 in) to 8 cm (3.1 in) across. Liver function still preserved: no jaundice, no ascites, no overt hepatic encephalopathy.
- Earlier treatment
- The target tumour must not have been treated before. No earlier systemic therapy for advanced liver cancer.
Main reasons for not taking part
- Tumour spread through the liver, to other organs, or into blood vessels
- Jaundice, uncontrolled fluid in the belly or chest, or hepatic encephalopathy
- Severe heart problems, severe low blood pressure, or heart attack in the last 6 months
- Life expectancy under 12 weeks
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Switzerland
- University Hospital BaselBasel, SwitzerlandContact: Fahim Ebrahimi, PD Dr.Taking people
- Hôpitaux universitaires de GenèveGeneva, SwitzerlandContact: Nicolas Goossens, PD Dr.Taking people
- Kantonsspital St. GallenSankt Gallen, SwitzerlandContact: David Semela, PD Dr.Taking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Experimental ArmTreatment being tested
Treatment: DEB-DoxNic-TACE
- Control ArmExisting treatment, for comparison
Treatment: current standard of care
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
- Plain-language title
- Adding nicardipine to chemoembolization for liver cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 March 2026