REGULUS: MRI-guided Adaptive SABR for Liver Cancers

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• 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.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• MRI: Part of the study plan
• radiation: Part of the study plan

Main goals

• 1-year Overall Survival (OS) (1 year after SABR)

Other goals

• Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events
• Rate of Grade ≥ 2 Radiation Pneumonitis
• Rate of Grade ≥ 2 Chest Wall Toxicity
• Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR
• Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR
• Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR
• Rate of Patients With Total Delivery Time > 120 Minutes

Planned enrollment: 62 (estimated).

• Stanford University, Palo Alto, California

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07223307

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 26, 2026. Public record; not medical advice.