Hepatocellular CarcinomaNCT01918683
TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients
A study testing TACE transarterial chemoembolization and stereotatic body radiotherapy (SBRT) in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.
Trial summary
This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE transarterial chemoembolization and stereotatic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Dec 2027
- 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
- Patient capable of giving informed consent
- Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed for orthotopic liver transplantation at the participating institution
- Age > 18 years old
- Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology
- Childs' Class A or B7
- Eastern Clinical Oncology Group performance status 0 or 1
Who cannot join
- Prior radiotherapy to the upper abdomen or radioembolization of the liver
- Prior TACE to the target lesion, RFA, or liver transplant
- Active GI bleed within 2 weeks of study enrollment
- Active GI ulcer disease within 4 weeks of study enrollment
- Ascites refractory to medical therapy
- Contraindication to receiving radiotherapy or TACE
Show all 10Show fewer
- Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
- Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
- Women who are pregnant
- Participation in another concurrent treatment protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Loyola University Medical Center
Maywood, Illinois, 60153
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. We propose the trial be conducted as a pilot clinical trial with the goal of enrolling 40 patients into each arm
Read the detailed description
The purpose of this study is to determine whether the combination of stereotatic body radiotherapy (SBRT) tand transarterial chemoembolization (TACE) is an effective "bridging therapy" for patients hepatocellular carcinoma (HCC) of the liver awaiting transplantation.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE transarterial chemoembolization, stereotatic body radiotherapy (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.
TACE transarterial chemoembolizationRadiation
stereotatic body radiotherapy (SBRT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| A -Tace alone | Other | A - TACE alone (control group, current practice and treatment) Receives: Radiation: TACE transarterial chemoembolization |
| B - Tace combined with SBRT | Experimental | B- TACE combined with SBRT (experimental group). Receives: Radiation: TACE transarterial chemoembolization; Radiation: stereotatic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
endpoint is OLT
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- two arms
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University, Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Edgar Ben-Josef, MD, Principal investigator, Abramson Cancer Center at Penn MedicineTarita Thomas, MD, PhD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918683
- Sponsor's protocol ID
- UPCC 16213
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2013
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Transarterial Chemoembolization With or Without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients Awaiting Liver Transplantation
- ClinicalTrials.gov ID
- NCT01918683
- Acronym / sponsor ID
- UPCC 16213
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Loyola University, Oregon Health and Science University
- Study start
- Jul 2013
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Aug 2013 (estimated)
- 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.
This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. We propose the trial be conducted as a pilot clinical trial with the goal of enrolling 40 patients into each arm
Detailed description
The purpose of this study is to determine whether the combination of stereotatic body radiotherapy (SBRT) tand transarterial chemoembolization (TACE) is an effective "bridging therapy" for patients hepatocellular carcinoma (HCC) of the liver awaiting transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two arms
| Arm | Type | Receives |
|---|---|---|
| A -Tace alone | Other | Radiation: TACE transarterial chemoembolizationA - TACE alone (control group, current practice and treatment) |
| B - Tace combined with SBRT | Experimental | Radiation: TACE transarterial chemoembolization, Radiation: stereotatic body radiotherapy (SBRT)B- TACE combined with SBRT (experimental group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient capable of giving informed consent
- Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed for orthotopic liver transplantation at the participating institution
- Age > 18 years old
- Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology
- Childs' Class A or B7
Key exclusion criteria (10 listed)
- Prior radiotherapy to the upper abdomen or radioembolization of the liver
- Prior TACE to the target lesion, RFA, or liver transplant
- Active GI bleed within 2 weeks of study enrollment
- Active GI ulcer disease within 4 weeks of study enrollment
- Ascites refractory to medical therapy
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 |
|---|---|---|
| TACE transarterial chemoembolization | Radiation | A -Tace alone, B - Tace combined with SBRT |
| stereotatic body radiotherapy (SBRT) | Radiation | B - Tace combined with SBRT |
Primary outcome
Progression Free Survival
Time frame: 10 days
endpoint is OLT
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 29 Jan 2026.
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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. This study is not recruiting at the moment.
Edgar Ben-Josef, MD principal investigator
Abramson Cancer Center at Penn Medicine
Tarita Thomas, MD, PhD principal investigator
Loyola University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE transarterial chemoembolization and stereotatic body radiotherapy (SBRT) in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.
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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 10 days). 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 29 Jan 2026.