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Compares treatment options for Hepato Cellular Carcinoma (HCC)
Official title Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07302919
What this study is testing
What is DEB-DoxNic-TACE?
DEB-DoxNic-TACE is an investigational medicine, being studied as a potential treatment for hepato cellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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,
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
- Geneva, Switzerland
- Sankt Gallen, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland; Geneva, Switzerland; Sankt Gallen, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.