DEB-DoxNic-TACE: TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads (DEB) loaded with 33mg/ml doxorubicin (Dox) and 0.3mg/mL nicardipine (Nic)
current standard of care: TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
complete response rate (CRR) — 3 month of the target lesion at time point 3 months after TACE assessed by mRECIST (modified response evaluation criteria in solid tumors) in four-phase CT or contrast MRI according to standard liver imaging protocols
progression-free survival (PFS) — up to 12 month as defined as time to progression of any tumor treated as part of the trial or death of a patient.
Trial sites (3)
Facility
City
Region
Status
University Hospital Basel
Basel
Switzerland
Recruiting
Hôpitaux Universitaires de Genève
Geneva
Switzerland
Recruiting
Kantonsspital St. Gallen
Sankt Gallen
Switzerland
Recruiting
More University Hospital, Basel, Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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