Liver CancerPhase 2NCT07223307
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
A Phase 2 study testing MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) in people with Liver Cancer and Intrahepatic Cholangiocarcinoma, run by Stanford University at 1 site in United States.
Trial summary
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases
- What is being tested?
- MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to Jan 2030
- 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
- Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion > 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
- ≥ 18 years old at time of study enrollment
- Child-Pugh A status
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life Expectancy > 6 months
- For women of childbearing potential or who are not postmenopausal (see Appendix F for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done.
- Ability to understand and the willingness to provide written informed consent.
- Patients treated with prior liver-directed therapies with the exception of radioembolization are eligible for this study if they otherwise meet eligibility criteria
Who cannot join
- Prior treatment with radioembolization
- Cytotoxic chemotherapy or investigational agent within 1 week of SABR
- Prior radiotherapy overlapping with study treatment site
- Female patients who are pregnant
- Contraindication to having an MRI scan or inability to tolerate MRI
- Presence of a pacemaker or other implanted cardiac device
- Direct tumor extension into the stomach, duodenum, small bowel or large bowel
- Patient unable to breath hold > 15 seconds
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
Stanford University
Palo Alto, California, 94304
Eleanor Brown, 650-497-8966, eleanor9@stanford.edu
Erqi L Pollom, MD
About this study
Official title: Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
- Conditions
- Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases, HCC
- Being tested
- MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)
- Medical subject headings
- Liver Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)Radiation
A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40 Gy delivered in one fraction using external beam techniques.
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR) | Experimental | Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. Receives: Radiation: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Overall Survival (OS)
Overall survival will be defined as the time from treatment to death from any cause. Patients alive at the time of analysis will be censored at last follow-up.
Measured: 1 year after SABR
Secondary outcomes (7)
Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events
Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 gastrointestinal adverse events (including fatigue, nausea, diarrhea, or GI pain) attributable to SABR.
Measured: Within 90 days of completing SABR
Rate of Grade ≥ 2 Radiation Pneumonitis
Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 radiation pneumonitis attributable to SABR.
Measured: Within 90 days of completing SABR
Rate of Grade ≥ 2 Chest Wall Toxicity
Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 chest wall toxicity attributable to SABR.
Measured: Within 90 days of completing SABR
Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR
Patient-reported global health status and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Scores range from 0 to 100, with higher scores indicating better global health status and overall quality of life.
Measured: Up to 1 year post-SABR
Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR
Patient-reported quality of life will be evaluated using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire.
The FACT-Hep consists of the FACT-General (FACT-G) plus additional hepatobiliary-specific items.
Total scores range from 0 to 180, with higher scores indicating better health-related quality of life.
Measured: Up to 1 year post-SABR
Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR
Financial toxicity will be assessed using the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire.
Scores range from 0 to 44, with higher scores indicating lower financial toxicity (better financial well-being).
Measured: Up to 1 year post-SABR
Rate of Patients With Total Delivery Time > 120 Minutes
Percentage of patients with total SABR delivery time exceeding 120 minutes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start23 Jan 2026
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Viewray Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223307
- Sponsor's protocol ID
- IRB-82587
- Other IDs
- NCI-2026-03472
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow
- ClinicalTrials.gov ID
- NCT07223307
- Acronym / sponsor ID
- IRB-82587
- Conditions
- Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases, HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Viewray Inc.
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 31 Oct 2025 (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.
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR) | Experimental | Radiation: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed HCC, intrahepatic cholangiocarcinoma, or metastatic cancer. In the case of suspected HCC in patients with known cirrhosis, noninvasive criteria recommended by the European Association for the Study of Liver Diseases (lesion > 1 cm with arterial phase hyperenhancement and venous phase washout) or LI-RADS score of 5 may be used
- ≥ 18 years old at time of study enrollment
- Child-Pugh A status
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life Expectancy > 6 months
Key exclusion criteria (8 listed)
- Prior treatment with radioembolization
- Cytotoxic chemotherapy or investigational agent within 1 week of SABR
- Prior radiotherapy overlapping with study treatment site
- Female patients who are pregnant
- Contraindication to having an MRI scan or inability to tolerate MRI
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 |
|---|---|---|
| MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)A single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) will be delivered using the MRIdian system. Treatment includes adaptive planning based on daily MRI imaging to update tumor and organ-at-risk contours and optimize the radiation dose. On the day of treatment, Eovist contrast is administered 20 minutes before therapy to enhance tumor visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion. The total dose is 30-40 Gy delivered in one fraction using external beam techniques. | Radiation | MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR) |
Primary outcome
1-year Overall Survival (OS)
Time frame: 1 year after SABR
Overall survival will be defined as the time from treatment to death from any cause. Patients alive at the time of analysis will be censored at last follow-up.
7 secondary outcomes
Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events
Time frame: Within 90 days of completing SABR
Rate of Grade ≥ 2 Radiation Pneumonitis
Time frame: Within 90 days of completing SABR
Rate of Grade ≥ 2 Chest Wall Toxicity
Time frame: Within 90 days of completing SABR
Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR
Time frame: Up to 1 year post-SABR
Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR
Time frame: Up to 1 year post-SABR
Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR
Time frame: Up to 1 year post-SABR
Rate of Patients With Total Delivery Time > 120 Minutes
Time frame: Baseline
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 27 Oct 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.
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 MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) in people with Liver Cancer and Intrahepatic Cholangiocarcinoma, run by Stanford University 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 8 inclusion and 8 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 27 Oct 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 Eleanor Brown (650-497-8966, eleanor9@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Overall Survival (OS) (time frame: 1 year after SABR). 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 27 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.