Hepatocellular Carcinoma Non-resectableASTrHNCT04996914
Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
A study testing TACE and SBRT in people with Hepatocellular Carcinoma Non-resectable, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- TACE and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 5 May 2026to 5 May 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC (diagnosis: histological or radiological)
- Age: 18-80
- Number of lesions 1-3 lesions
- Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm
- Sufficient non-tumorous liver volume (≥ 800 cm3)
- Child Pugh Score: A5-6 or B7-8
Show all 13Show fewer
- BCLC A or B
- Patient is illegible or refused surgical resection or orthotopic liver transplant
- Blood work (within 2 weeks before registration):
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³)
- Platelets ≥50,000 cells/mm³
- AST (and ALT) < 5 times ULN
- Serum creatinine ≤ ULN or creatinine clearance ≥ 50 mL/min
Who cannot join
- Evidence of extrahepatic disease (lymph node or distant metastases)
- Evidence of macroscopic vascular invasion
- Evidence of an arterio-portal or arterio-venous fistulas
- History of previous malignancy
- Previous SIRT
- Previous Sorafenib in the last 8 weeks
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
Ahmed Allam Mohamed, PD. Dr. MSc. MBBCh., +492418089260, amohamed@ukaachen.de
About this study
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
- Conditions
- Hepatocellular Carcinoma Non-resectable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference.
SBRTRadiation
SBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged.
Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy)
| Study group | Role | What they receive |
|---|---|---|
| TACE+SBRT. | Experimental | If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session . Receives: Procedure: TACE; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year local control rate
After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion).
Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)
Measured: 12 Months
Secondary outcomes (5)
1- year progression free survival
After one year from the end of the treatment, the percentage of alive subjects without the apperance of new hepatic and/or extra-heaptic new lesions outside the SBRT-field.
This will be measured using contrast-enhanced CT scan Liver/Abdomen and Thorax
Measured: 12 Months
Qualtiy of life based on EORTC QLQC30
alive subjects will fill quality of life questionnaires (EORTC QLQC30) before the treatment and after 3,6 and 12 months after.
The results before and after the treatment will be presented in comaprsion to the reference data.
Measured: 12 Months
Quality of life based on EORTC QLQ-HCC18
alive subjects will fill quality of life questionnaires (EORTC QLQ-HCC18) before the treatment and after 3,6 and 12 months after.
The results before and after the treatment will be presented in comaprsion to the reference data.
Measured: 12 Months
Possibility of a secondary resection/organ transplant
Possibility of a secondary resection/organ transplant (Yes/ No)
Measured: 3 Years
Side effects
will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 and Child Pugh Score change till 6 months after the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start5 May 2026
- Primary completion5 May 2028 (estimated)
- Study completion5 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J. Eble, Professor Dr. med., Study chair, University medical center RWTH AachenPhilipp Bruners, Professor Dr. med., Study chair, University medical center RWTH AachenAhmed Allam Mohamed, MBBS, MSc, MD, Study chair, University medical center RWTH AachenOliver Beetz, Prof. Dr.med . MHBA, Study chair, University medical center RWTH AachenMarie-Luise Berres, Prof. Dr.med., Study chair, University medical center RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996914
- Sponsor's protocol ID
- 20-341
- Acronym
- ASTrH
- Status last verified
- May 2026
- First submitted
- 2 Jul 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04996914
- Acronym / sponsor ID
- ASTrH / 20-341
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 5 May 2028 (estimated)
- Study completion
- 5 May 2029 (estimated)
- First posted
- 9 Aug 2021 (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.
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE+SBRT. | Experimental | Procedure: TACE, Radiation: SBRTIf a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- HCC (diagnosis: histological or radiological)
- Age: 18-80
- Number of lesions 1-3 lesions
- Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm
- Sufficient non-tumorous liver volume (≥ 800 cm3)
Key exclusion criteria (7 listed)
- Evidence of extrahepatic disease (lymph node or distant metastases)
- Evidence of macroscopic vascular invasion
- Evidence of an arterio-portal or arterio-venous fistulas
- History of previous malignancy
- Previous SIRT
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 |
|---|---|---|
| TACE1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference. | Procedure or surgery | TACE+SBRT. |
| SBRTSBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged. Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy) | Radiation | TACE+SBRT. |
Primary outcome
1-year local control rate
Time frame: 12 Months
After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)
5 secondary outcomes
1- year progression free survival
Time frame: 12 Months
Qualtiy of life based on EORTC QLQC30
Time frame: 12 Months
Quality of life based on EORTC QLQ-HCC18
Time frame: 12 Months
Possibility of a secondary resection/organ transplant
Time frame: 3 Years
Side effects
Time frame: 6 months
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 11 May 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.
Michael J. Eble, Professor Dr. med. study chair
University medical center RWTH Aachen
Philipp Bruners, Professor Dr. med. study chair
University medical center RWTH Aachen
Ahmed Allam Mohamed, MBBS, MSc, MD study chair
University medical center RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE and SBRT in people with Hepatocellular Carcinoma Non-resectable, run by RWTH Aachen University 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 13 inclusion and 7 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 11 May 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 Ahmed Allam Mohamed, MBBS,MSc, MD (+49241 80-8926, amohamed@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year local control rate (time frame: 12 Months). 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 11 May 2026.