Hepato Cellular Carcinoma (HCC)Phase 2/3IMPACT-TACENCT07302919
Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma
A Phase 2/3 study testing DEB-DoxNic-TACE in people with Hepato Cellular Carcinoma (HCC), run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC)
- What is being tested?
- DEB-DoxNic-TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 16 Feb 2026to Jun 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Fahim Ebrahimi, PD Dr., +41 61 777 74 38, fahim.ebrahimi@clarunis.ch
Markus Heim, Prof.
- Recruiting
Hôpitaux Universitaires de Genève
Geneva, 1205
Nicolas Goossens, PD Dr.
Nicolas Goossens, PD Dr.
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9007
David Semela, PD Dr.
David Semela, PD Dr.
About this study
Official title: Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
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.
Read the detailed description
Liver cancer, also known as hepatocellular carcinoma (HCC), is the sixth most common tumor disease worldwide. It is an aggressive cancer that is very often fatal, as it is usually detected at a late stage when surgery is no longer possible. International guidelines recommend transarterial chemoembolization (TACE) as the treatment of choice in such cases, as this therapy can prolong survival. In such cases, international guidelines recommend transarterial chemoembolization (TACE) as the treatment of choice, as this therapy can prolong survival. TACE is a widely used interventional method in which a thin catheter is advanced to the liver artery supplying the tumor. Tiny beads loaded with a chemotherapeutic agent (doxorubicin) are then injected directly into the tumor nodules. The beads block the artery supplying the tumor, interrupting the blood supply to the tumor and causing it to die. In addition, the beads slowly release the chemotherapy drug doxorubicin into the tumor, which is intended to contribute to the complete death of the tumor cells. However, the studies also showed that complete death of the tumor node could only be achieved in approximately 25% of patients. The latest study results have revealed that one of the main causes of the incomplete response to TACE therapy is that cancer cells develop resistance to protect themselves against the chemotherapy drug doxorubicin. This resistance can be circumvented by inhibiting the enzyme ABCB1, allowing the chemotherapy drug to act on the tumor cells and kill them completely. The blood pressure medication nicardipine has a strong inhibitory effect on this enzyme. In this study, the investigators therefore want to investigate whether the response to TACE therapy can be improved by administering beads that release the active ingredient nicardipine in the tumor in addition to the chemotherapy drug doxorubicin, so that the tumor nodule cannot develop resistance and dies completely.
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Being tested
- DEB-DoxNic-TACE, current standard of care
- Keywords
- Transarterial Chemoembolization (TACE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-DoxNic-TACECombination product
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 careCombination product
TACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Combination Product: DEB-DoxNic-TACE |
| Control Arm | Active comparator | Not described Receives: Combination Product: current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month
progression-free survival (PFS)
as defined as time to progression of any tumor treated as part of the trial or death of a patient.
Measured: up to 12 month
Secondary outcomes (6)
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).
Measured: 3 month
Duration of response (DOR)
Measured: up to 12 month
Change in tumor markers
Measured: 3 and 6 month
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.
Measured: up to 1 year
Overall survival
Measured: up to 12 month
Complete response of the target lesion
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start16 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Parallel, Controlled, Multicenter Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahim Ebrahimi, PD Dr., Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302919
- Sponsor's protocol ID
- 2024-02072, bb24heim
- Acronym
- IMPACT-TACE
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Parallel, Controlled, Multicenter Study of Transarterial Chemoembolization (TACE) Plus ABCB1 Inhibition Versus TACE Alone in Patients With Hepatocellular Carcinoma: IMPACT-TACE
- ClinicalTrials.gov ID
- NCT07302919
- Acronym / sponsor ID
- IMPACT-TACE / 2024-02072, bb24heim
- Conditions
- Hepato Cellular Carcinoma (HCC)
- Keywords
- Transarterial Chemoembolization (TACE)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Liver cancer, also known as hepatocellular carcinoma (HCC), is the sixth most common tumor disease worldwide. It is an aggressive cancer that is very often fatal, as it is usually detected at a late stage when surgery is no longer possible. International guidelines recommend transarterial chemoembolization (TACE) as the treatment of choice in such cases, as this therapy can prolong survival. In such cases, international guidelines recommend transarterial chemoembolization (TACE) as the treatment of choice, as this therapy can prolong survival. TACE is a widely used interventional method in which a thin catheter is advanced to the liver artery supplying the tumor. Tiny beads loaded with a chemotherapeutic agent (doxorubicin) are then injected directly into the tumor nodules. The beads block the artery supplying the tumor, interrupting the blood supply to the tumor and causing it to die. In addition, the beads slowly release the chemotherapy drug doxorubicin into the tumor, which is intended to contribute to the complete death of the tumor cells. However, the studies also showed that complete death of the tumor node could only be achieved in approximately 25% of patients. The latest study results have revealed that one of the main causes of the incomplete response to TACE therapy is that cancer cells develop resistance to protect themselves against the chemotherapy drug doxorubicin. This resistance can be circumvented by inhibiting the enzyme ABCB1, allowing the chemotherapy drug to act on the tumor cells and kill them completely. The blood pressure medication nicardipine has a strong inhibitory effect on this enzyme. In this study, the investigators therefore want to investigate whether the response to TACE therapy can be improved by administering beads that release the active ingredient nicardipine in the tumor in addition to the chemotherapy drug doxorubicin, so that the tumor nodule cannot develop resistance and dies completely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Parallel, Controlled, Multicenter Study
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Combination Product: DEB-DoxNic-TACE |
| Control Arm | Active comparator | Combination Product: current standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (13 listed)
- Any prior systemic therapy for advanced HCC,
- Diffuse tumor lesions, extrahepatic metastases, or vascular invasion,
- Hepatic encephalopathy,
- Uncontrolled ascites or pleural effusion,
- Jaundice,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEB-DoxNic-TACETACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads (DEB) loaded with 33mg/ml doxorubicin (Dox) and 0.3mg/mL nicardipine (Nic) | Combination product | Experimental Arm |
| current standard of careTACE (transarterial chemoembolization) with 1-3 mL drug-eluting beads loaded with 33mg/ml doxorubicin | Combination product | Control Arm |
Primary outcome
complete response rate (CRR)
Time frame: 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)
Time frame: up to 12 month
as defined as time to progression of any tumor treated as part of the trial or death of a patient.
6 secondary outcomes
Objective response rate (ORR)
Time frame: 3 month
Duration of response (DOR)
Time frame: up to 12 month
Change in tumor markers
Time frame: 3 and 6 month
Patient-reported outcomes
Time frame: up to 1 year
Overall survival
Time frame: up to 12 month
Complete response of the target lesion
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fahim Ebrahimi, PD Dr. study director
University Hospital, Basel, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DEB-DoxNic-TACE in people with Hepato Cellular Carcinoma (HCC), run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fahim Ebrahimi, PD Dr. (+41 61 777 74 00, fahim.ebrahimi@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (CRR) (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.