Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation (TREASURE-Tx)

November 3, 2026 updated by: AIO-Studien-gGmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ursula Ehmer, PD Dr. med.
  • Phone Number: +49 (0) 89 4140-9324
  • Email: ursula.ehmer@tum.de

Study Contact Backup

Study Locations

  • Germany
      • München, Germany, 81675
        • Recruiting
        • Klinik und Poliklinik für Innere Medizin II, TUM Klinikum, Rechts der Isar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent obtained from the subject prior to performing any protocol related procedures, including screening evaluations.

  2. Age ≥ 18 years at time of study entry.

  3. 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.

  4. Patients planned for liver transplantation after discussion within a multidisciplinary board.

  5. 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).

  6. 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).

  7. At least one measurable site of disease with spiral CT scan or MRI according to mRECIST for HCC.

  8. Sufficient liver function (< Child Pugh B8)

  9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

  10. Adequate blood count, liver enzymes and renal function:

    1. Hemoglobin ≥ 7 g/dL, absolute neutrophil count ≥ 1000 /µL, platelets ≥ 35000/µL
    2. Total bilirubin and serum albumin as part of Child Pugh requirement
    3. ALAT and ASAT ≤5 x ULN

  11. 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

  12. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 14 days prior to start of the study (randomization).

  13. 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.

  14. 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.

Exclusion Criteria:

  1. Involvement in the planning and/or conduct of the study.
  2. Prior local tumor specific treatment of the same tumor nodule within the last 24 months.
  3. Histological proven fibrolamellar HCC or mixed HCC/cholangiocarcinoma.
  4. Other invasive malignancies within the past 2 years (except for non-melanoma skin cancer or non-invasive bladder cancer).
  5. Impaired liver function Child-Pugh Class B > 7.
  6. 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.
  7. Dementia or significantly altered mental status that would prohibit the understanding or rendering of information, consent, and compliance with the requirements of the protocol.
  8. Pregnancy and breastfeeding. Should a patient become pregnant, the treating physician has to be informed immediately.
  9. 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.
  10. Weight less than or equal to 30 kg.
  11. Prior radiotherapy to the upper abdomen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: The patients will receive two procedures of TACE prior to liver transplantation

Standard arm: The patients will receive two procedures of TACE prior to liver transplantation
Procedure: The patients will receive two procedures of TACE prior to liver transplantation

The patients will receive two procedures of TACE prior to liver transplantation as bridging therapy (standard of care)
Experimental: The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation

Experimental arm: The patients will receive two procedures of TACE followed by SBRT prior to liver transplantation
Procedure: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation

The patients will receive a stereotactic body radiation therapy (SBRT) in addition to two procedures of TACE prior to liver transplantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After liver transplantation (at least 24 months after randomization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 24 months after randomization

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.
24 months after randomization
Objective response rate (ORR)
Time Frame: up to 24 months after randomization

The objective response rate (ORR) is defined as the proportion of all randomized patients in whom a CR or PR was observed
up to 24 months after randomization
Complete response rate (CRR)
Time Frame: up to 24 months after randomization

The complete response rate (CRR) is defined as the proportion of all randomized patients in whom a CR was observed
up to 24 months after randomization
Progression-free survival (PFS)
Time Frame: up to 24 months after randomization

Progression-free survival (PFS) is defined as time from randomization to objective tumor progression or death from any cause
up to 24 months after randomization
Recurrence Rate
Time Frame: up to 24 months after transplantation

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.
up to 24 months after transplantation
Recurrence free survival (RFS)
Time Frame: up to 24 months after transplantation

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.
up to 24 months after transplantation
Quality of Life Assessments
Time Frame: up to 24 months after randomization

Quality of Life evaluated with EQ-5D-5L
up to 24 months after randomization
Safety reporting - treatment-emergent adverse events
Time Frame: Up to 24 months after informed consent

Type, incidence, causal relationship, and severity of treatment-emergent adverse events
Up to 24 months after informed consent
Safety reporting - albumin-bilirubin score (ALBI Score)
Time Frame: Up to 24 months after informed consent

Analysis of the effect on albumin-bilirubin score (ALBI Score)
Up to 24 months after informed consent
Safety reporting - Child Pugh Score
Time Frame: Up to 24 months after informed consent

Analysis of the effect on Child Pugh Score
Up to 24 months after informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AIO-Studien-gGmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIO-HEP-0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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