Heptocellular CancerPhase 2REVERTNCT07530172
Radioembolization Versus External Radiation Therapy
A Phase 2 study testing Transarterial Radioembolization and Stereotactic Body Radiation Therapy (SBRT) in people with Heptocellular Cancer, run by Henry Ford Health System at 1 site in United States.
Trial summary
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heptocellular Cancer
- What is being tested?
- Transarterial Radioembolization and Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to 31 Dec 2029
- Phase
- Phase 2
- 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
- Ability to provide written informed consent and HIPAA authorization
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years at time of informed consent
- No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
- Childs-Pugh score ≤ 8
- ECOG performance status ≤2
Show all 9Show fewer
- Adequate organ function defined as:
- serum bilirubin < 4.0 mg/dL ,
- albumin > 2 g/dL
Who cannot join
- Any prior SBRT or radioembolization to the target tumor
- Macrovascular invasion
- Planned or recommended systemic therapy as consolidation
- Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.
- Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Marissa Gilbert, 3135568422, mgilber6@hfhs.org
About this study
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
- Conditions
- Heptocellular Cancer
- Being tested
- Transarterial Radioembolization, Stereotactic Body Radiation Therapy (SBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial RadioembolizationRadiation
The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.
Stereotactic Body Radiation Therapy (SBRT)Radiation
The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.
| Study group | Role | What they receive |
|---|---|---|
| TARE | Experimental | The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. Receives: Radiation: Transarterial Radioembolization |
| SBRT | Experimental | The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of re-treatment over 12 months
Rate of re-treatment of the index lesion over 12 months
Measured: From enrollment to 12 months following the end of treatment
Secondary outcomes (10)
Laboratory toxicities CBC
Laboratory CBC (includes WBC (k/uL), RBC (M/uL), and Platelets (K/uL)
Measured: From enrollment to 24 months post treatment
Laboratory toxicities CMP
Laboratory CMP (includes Sodium (mmol/L), Creatine (mg/dL), Total Bilirubin (mg/dL), ALP (IU/L), AST/SGOT (IU/L), ALT/SGPT (IU/L), Serum Albumin (g/dl), INR (unitless), AFP (ng/mL)
Measured: From enrollment to 24 months post treatment
Laboratory toxicities INR
Laboratory INR (unitless)
Measured: From enrollment to 24 months post treatment
Laboratory toxicities AFP
Laboratory AFP (ng/mL)
Measured: From enrollment to 24 months post treatment
Clinical toxicities
Clinical toxicities measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Scale of 1 to 5 with 5 being the worst outcome.
Measured: From enrollment to 24 months post treatment
Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.
Change in patient reported outcomes
Measured: From enrollment to 1, 3, and 6 months post treatment
Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.
Change in patient reported outcomes
Measured: From enrollment to 1, 3, and 6 months post treatment
Disease Free Survival
DFS at 2 years
Measured: From enrollment to 24 months post treatment
Local Control
LC at 6 months after completion of treatment using LIRADS on multiphase CT or MR
Measured: From enrollment to 6 months post treatment
Overall Survival
OS at 2 years
Measured: From enrollment to 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start8 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heptocellular CancerStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reena Salgia, Henry Ford Health System
- Investigators
- Reena Salgia, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530172
- Sponsor's protocol ID
- 18805
- Acronym
- REVERT
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioembolization Versus External Radiation Therapy
- ClinicalTrials.gov ID
- NCT07530172
- Acronym / sponsor ID
- REVERT / 18805
- Conditions
- Heptocellular Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Apr 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.
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TARE | Experimental | Radiation: Transarterial RadioembolizationThe TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. |
| SBRT | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written informed consent and HIPAA authorization
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years at time of informed consent
- No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
- Childs-Pugh score ≤ 8
Key exclusion criteria (5 listed)
- Any prior SBRT or radioembolization to the target tumor
- Macrovascular invasion
- Planned or recommended systemic therapy as consolidation
- Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.
- Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial 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 |
|---|---|---|
| Transarterial RadioembolizationThe TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. | Radiation | TARE |
| Stereotactic Body Radiation Therapy (SBRT)The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. | Radiation | SBRT |
Primary outcome
Rate of re-treatment over 12 months
Time frame: From enrollment to 12 months following the end of treatment
Rate of re-treatment of the index lesion over 12 months
10 secondary outcomes
Laboratory toxicities CBC
Time frame: From enrollment to 24 months post treatment
Laboratory toxicities CMP
Time frame: From enrollment to 24 months post treatment
Laboratory toxicities INR
Time frame: From enrollment to 24 months post treatment
Laboratory toxicities AFP
Time frame: From enrollment to 24 months post treatment
Clinical toxicities
Time frame: From enrollment to 24 months post treatment
Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.
Time frame: From enrollment to 1, 3, and 6 months post treatment
Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.
Time frame: From enrollment to 1, 3, and 6 months post treatment
Disease Free Survival
Time frame: From enrollment to 24 months post treatment
Local Control
Time frame: From enrollment to 6 months post treatment
Overall Survival
Time frame: From enrollment to 24 months post treatment
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 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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.
Reena Salgia, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transarterial Radioembolization and Stereotactic Body Radiation Therapy (SBRT) in people with Heptocellular Cancer, run by Henry Ford Health System at 1 site 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 9 inclusion and 5 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 15 Apr 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marissa Gilbert (313-556-8422, mgilber6@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of re-treatment over 12 months (time frame: From enrollment to 12 months following the end of treatment). 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 15 Apr 2026.