HCC - Hepatocellular CarcinomaTREASURE-TxNCT07924943
Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation
A study testing Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation and The patients will receive two procedures of TACE prior to liver transplantation in people with HCC - Hepatocellular Carcinoma, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
In this randomised study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation and The patients will receive two procedures of TACE prior to liver transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jul 2026to Mar 2031
- Phase
- Interventional
- 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
- Written informed consent obtained from the subject prior to performing any protocol related procedures, including screening evaluations.
- Age ≥ 18 years at time of study entry.
- HCC diagnosed by histopathology and/or according to EASL or AASLD criteria at an early stage (BCLC A or UNOS T2), without any curative treatment option (resection or ablation) other than liver transplantation as determined by tumor board decision of at least one tumor lesion. Guidance: Patients with prior HCC who had surgery or locoregional treatment and had a complete remission for over 2 years and develop denovo HCC at a location different from previously treated HCC lesion(s) are eligible to participate.
- Patients planned for liver transplantation after discussion within a multidisciplinary board.
- Patients eligible to receive a matchReMELD-Na (SE-ReMELD-Na) - Score for hepatocellular carcinoma according to German transplant regulations. Guidance: All listing assessments must be completed before first on-study radiologic tumor assessment (first radiologic tumor assessment in treatment follow-up).
- Treatment of all lesions by SBRT is feasible as determined by the local physician. The central review board recommendation process has been initiated (i.e. image upload by site).
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- At least one measurable site of disease with spiral CT scan or MRI according to mRECIST for HCC.
- Sufficient liver function (< Child Pugh B8)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Adequate blood count, liver enzymes and renal function:
- Hemoglobin ≥ 7 g/dL, absolute neutrophil count ≥ 1000 /µL, platelets ≥ 35000/µL
- Total bilirubin and serum albumin as part of Child Pugh requirement
- ALAT and ASAT ≤5 x ULN
- Patients with active HIV Infection must show a CD4 cell count above 200/µL and no detectable HIV RNA for at least three months prior to the study
- Female patients with reproductive potential must have a negative urine or serum pregnancy test within 14 days prior to start of the study (randomization).
- Patients of childbearing potential who are sexually active must use an adequate contraceptive method with a failure rate less than 1 % per year. Enrolled patients must agree to use adequate contraception for the duration of study treatment and up to 6 months after the end of the treatment (depending on treatment received), manufactures recommendation (TACE) and local guidelines.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Involvement in the planning and/or conduct of the study.
- Prior local tumor specific treatment of the same tumor nodule within the last 24 months.
- Histological proven fibrolamellar HCC or mixed HCC/cholangiocarcinoma.
- Other invasive malignancies within the past 2 years (except for non-melanoma skin cancer or non-invasive bladder cancer).
- Impaired liver function Child-Pugh Class B > 7.
- Ongoing or active systemic infection or psychiatric illness/social situations that would limit compliance with study requirements. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
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- Dementia or significantly altered mental status that would prohibit the understanding or rendering of information, consent, and compliance with the requirements of the protocol.
- Pregnancy and breastfeeding. Should a patient become pregnant, the treating physician has to be informed immediately.
- Any condition, comorbidity or circumstance that, in the opinion of the investigator, would interfere with evaluation of study treatment or affect patient safety or study results.
- Weight less than or equal to 30 kg.
- Prior radiotherapy to the upper abdomen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ulrike Bauer, Dr. med. univ. Dr. med. contact
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Innere Medizin II, TUM Klinikum, Rechts der Isar
München, 81675
Ursula Ehmer, PD Dr. med., +49 (0) 89 4140-9324, ursula.ehmer@mri.tum.de
About this study
Official title: Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation A Randomized, 2-arm Phase II Study Comparing the Combination of Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) Versus TACE Alone in Patients With Hepatocellular Carcinoma as Bridging to Liver Transplantation With Regard to Explant Histopathology
In this randomised study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the most frequent malignancies worldwide and is characterized by a rising incidence. A first line curative treatment option is surgical resection. As most patients with HCC suffer from liver cirrhosis, resection is often constrained due to limited liver function. In patients with tumors within Milan criteria, liver transplantation remains a curative therapeutic option even if liver resection is not feasible. Due to organ shortage, there are long waiting periods and waitlist withdrawal because of tumor progression remains an eminent risk. Hence, bridging therapies are used to halt tumor growth. Transarterial chemoembolization (TACE) is one of the most commonly used bridging therapies. Other possible bridging therapies are local ablation and stereotactic body radiation therapy (SBRT). Importantly, there are several studies showing a potential benefit of the combination of TACE and SBRT in the treatment of HCC. Recently, we were able to show a high rate of complete histopathological response in patients who were treated with a combination of TACE and SBRT as bridging to liver transplant, suggesting a potential benefit of combining both therapies in a pre-transplant setting.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation, The patients will receive two procedures of TACE prior to liver transplantation
- Keywords
- HCC, TACE, SBRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantationProcedure or surgery
The patients will receive a stereotactic body radiation therapy (SBRT) in addition to two procedures of TACE prior to liver transplantation
The patients will receive two procedures of TACE prior to liver transplantationProcedure or surgery
The patients will receive two procedures of TACE prior to liver transplantation as bridging therapy (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| The patients will receive two procedures of TACE prior to liver transplantation | Active comparator | Standard arm: The patients will receive two procedures of TACE prior to liver transplantation Receives: Procedure: The patients will receive two procedures of TACE prior to liver transplantation |
| The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation | Experimental | Experimental arm: The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation Receives: Procedure: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: histopathological response (presence of vital tumor tissue) in explant histopathology after liver transplantation.
The percentage of vital tumor tissue is defined as the maximum percentage of vital tumor tissue per surface area per patient.
Measured: After liver transplantation (at least 24 months after randomization)
Secondary outcomes (10)
Overall survival (OS)
Overall survival (OS) is defined as time from randomization to death from any cause. Overall survival-rate at 24 months is defined as the (estimated) proportion of patients who are still alive 24 months after randomization.
Measured: 24 months after randomization
Objective response rate (ORR)
The objective response rate (ORR) is defined as the proportion of all randomized patients in whom a CR or PR was observed
Measured: up to 24 months after randomization
Complete response rate (CRR)
The complete response rate (CRR) is defined as the proportion of all randomized patients in whom a CR was observed
Measured: up to 24 months after randomization
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as time from randomization to objective tumor progression or death from any cause
Measured: up to 24 months after randomization
Recurrence Rate
Recurrence Rate is defined as the percentage of patients in whom cancer recurs after transplantation within 24 months. The recurrence is determined by regular standard of care follow-up examinations, which include imaging procedures (CT, MRI, ultrasound) and blood tests (e.g. alpha-fetoprotein). A division is made between local recurrence in the transplanted liver and distant metastases.
Measured: up to 24 months after transplantation
Recurrence free survival (RFS)
Recurrence free survival (RFS) is defined as time from transplantation to tumor recurrence or death from HCC. Death from any other cause will be used as a censoring event.
Measured: up to 24 months after transplantation
Quality of Life Assessments
Quality of Life evaluated with EQ-5D-5L
Measured: up to 24 months after randomization
Safety reporting - treatment-emergent adverse events
Type, incidence, causal relationship, and severity of treatment-emergent adverse events
Measured: Up to 24 months after informed consent
Safety reporting - albumin-bilirubin score (ALBI Score)
Analysis of the effect on albumin-bilirubin score (ALBI Score)
Measured: Up to 24 months after informed consent
Safety reporting - Child Pugh Score
Analysis of the effect on Child Pugh Score
Measured: Up to 24 months after informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start28 Jul 2026
- Primary completionJan 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TACE is performed as clinical standard in both study arms followed by study related conduct of SBRT in the experimental arm
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924943
- Sponsor's protocol ID
- AIO-HEP-0124
- Acronym
- TREASURE-Tx
- Status last verified
- Nov 2026
- First submitted
- 16 Sep 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation A Randomized, 2-arm Phase II Study Comparing the Combination of Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) Versus TACE Alone in Patients With Hepatocellular Carcinoma as Bridging to Liver Transplantation With Regard to Explant Histopathology
- ClinicalTrials.gov ID
- NCT07924943
- Acronym / sponsor ID
- TREASURE-Tx / AIO-HEP-0124
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- HCC, TACE, SBRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 9 Nov 2026 (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.
In this randomised study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.
Detailed description
Hepatocellular carcinoma (HCC) is one of the most frequent malignancies worldwide and is characterized by a rising incidence. A first line curative treatment option is surgical resection. As most patients with HCC suffer from liver cirrhosis, resection is often constrained due to limited liver function. In patients with tumors within Milan criteria, liver transplantation remains a curative therapeutic option even if liver resection is not feasible. Due to organ shortage, there are long waiting periods and waitlist withdrawal because of tumor progression remains an eminent risk. Hence, bridging therapies are used to halt tumor growth. Transarterial chemoembolization (TACE) is one of the most commonly used bridging therapies. Other possible bridging therapies are local ablation and stereotactic body radiation therapy (SBRT). Importantly, there are several studies showing a potential benefit of the combination of TACE and SBRT in the treatment of HCC. Recently, we were able to show a high rate of complete histopathological response in patients who were treated with a combination of TACE and SBRT as bridging to liver transplant, suggesting a potential benefit of combining both therapies in a pre-transplant setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TACE is performed as clinical standard in both study arms followed by study related conduct of SBRT in the experimental arm
| Arm | Type | Receives |
|---|---|---|
| The patients will receive two procedures of TACE prior to liver transplantation | Active comparator | Procedure: The patients will receive two procedures of TACE prior to liver transplantationStandard arm: The patients will receive two procedures of TACE prior to liver transplantation |
| The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation | Experimental | Procedure: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantationExperimental arm: The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Written informed consent obtained from the subject prior to performing any protocol related procedures, including screening evaluations.
- Age ≥ 18 years at time of study entry.
- HCC diagnosed by histopathology and/or according to EASL or AASLD criteria at an early stage (BCLC A or UNOS T2), without any curative treatment option (resection or ablation) other than liver transplantation as determined by tumor board decision of at least one tumor lesion. Guidance: Patients with prior HCC who had surgery or locoregional treatment and had a complete remission for over 2 years and develop denovo HCC at a location different from previously treated HCC lesion(s) are eligible to participate.
- Patients planned for liver transplantation after discussion within a multidisciplinary board.
- Patients eligible to receive a matchReMELD-Na (SE-ReMELD-Na) - Score for hepatocellular carcinoma according to German transplant regulations. Guidance: All listing assessments must be completed before first on-study radiologic tumor assessment (first radiologic tumor assessment in treatment follow-up).
Key exclusion criteria (11 listed)
- Involvement in the planning and/or conduct of the study.
- Prior local tumor specific treatment of the same tumor nodule within the last 24 months.
- Histological proven fibrolamellar HCC or mixed HCC/cholangiocarcinoma.
- Other invasive malignancies within the past 2 years (except for non-melanoma skin cancer or non-invasive bladder cancer).
- Impaired liver function Child-Pugh Class B > 7.
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 |
|---|---|---|
| Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantationThe patients will receive a stereotactic body radiation therapy (SBRT) in addition to two procedures of TACE prior to liver transplantation | Procedure or surgery | The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation |
| The patients will receive two procedures of TACE prior to liver transplantationThe patients will receive two procedures of TACE prior to liver transplantation as bridging therapy (standard of care) | Procedure or surgery | The patients will receive two procedures of TACE prior to liver transplantation |
Primary outcome
Primary Endpoint: histopathological response (presence of vital tumor tissue) in explant histopathology after liver transplantation.
Time frame: After liver transplantation (at least 24 months after randomization)
The percentage of vital tumor tissue is defined as the maximum percentage of vital tumor tissue per surface area per patient.
10 secondary outcomes
Overall survival (OS)
Time frame: 24 months after randomization
Objective response rate (ORR)
Time frame: up to 24 months after randomization
Complete response rate (CRR)
Time frame: up to 24 months after randomization
Progression-free survival (PFS)
Time frame: up to 24 months after randomization
Recurrence Rate
Time frame: up to 24 months after transplantation
Recurrence free survival (RFS)
Time frame: up to 24 months after transplantation
Quality of Life Assessments
Time frame: up to 24 months after randomization
Safety reporting - treatment-emergent adverse events
Time frame: Up to 24 months after informed consent
Safety reporting - albumin-bilirubin score (ALBI Score)
Time frame: Up to 24 months after informed consent
Safety reporting - Child Pugh Score
Time frame: Up to 24 months after informed consent
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 9 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Ulrike Bauer, Dr. med. univ. Dr. med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation and The patients will receive two procedures of TACE prior to liver transplantation in people with HCC - Hepatocellular Carcinoma, run by AIO-Studien-gGmbH at 1 site in Germany.
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 17 inclusion and 11 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 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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 Ursula Ehmer, PD Dr. med. (+49 (0) 89 4140-9324, ursula.ehmer@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: histopathological response (presence of vital tumor tissue) in explant histopathology after liver transplantation. (time frame: After liver transplantation (at least 24 months after randomization)). 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 9 Nov 2026.