Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
Recruiting
Phase 2Phase 3Interventional Study
Hepato Cellular Carcinoma (HCC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
152 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.