💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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