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.
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,
Any prior systemic therapy for advanced HCC,
Diffuse tumor lesions, extrahepatic metastases, or vascular invasion,
Hepatic encephalopathy,
Uncontrolled ascites or pleural effusion,
Parallel
DEB-DoxNic-TACE
Combination productTACE (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
Combination productTACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin
complete response rate (CRR)
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)
as defined as time to progression of any tumor treated as part of the trial or death of a patient.
Objective response rate (ORR)
Objective response (complete and partial) of the target lesion at time point 3 months assessed by mRECIST (modified response evaluation criteria in solid tumors).
Duration of response (DOR)
Change in tumor markers
Patient-reported outcomes
EuroQol 5-Dimension Questionnaire; 5-level version (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
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