An interventional study of 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 HCC - Hepatocellular Carcinoma, sponsored by AIO-Studien-gGmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by AIO-Studien-gGmbH · Not applicable, Interventional, and Treatment
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.
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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 44 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →AIO-Studien-gGmbH is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate blood count, liver enzymes and renal function:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
The patients will receive two procedures of TACE prior to liver transplantation as bridging therapy (standard of care)
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.
Time frame: After liver transplantation (at least 24 months after randomization)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: up to 24 months after transplantation
Quality of Life Assessments
Quality of Life evaluated with EQ-5D-5L
Time frame: up to 24 months after randomization
Safety reporting - treatment-emergent adverse events
Type, incidence, causal relationship, and severity of treatment-emergent adverse events
Time frame: Up to 24 months after informed consent
Safety reporting - albumin-bilirubin score (ALBI Score)
Analysis of the effect on albumin-bilirubin score (ALBI Score)
Time frame: Up to 24 months after informed consent
Safety reporting - Child Pugh Score
Analysis of the effect on Child Pugh Score
Time frame: Up to 24 months after informed consent
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2031, 54 months after the start.
Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 54 months is above that.
Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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