RecruitingPhase 2NCT07223307

REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Phase II Trial of REal Time MRI GUided Adaptive Stereotactic Ablative Radiotherapy for Liver Cancers Using a Single Session, Simulation Free Workflow

Sponsor

Stanford University

Enrollment

62 participants

Start Date

Jan 23, 2026

Study Type

INTERVENTIONAL

Conditions

Liver Cancer Liver Metastases Intrahepatic Cholangiocarcinoma HCC

Summary

Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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

Exclusion Criteria8

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

Interventions

RADIATIONMRI-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.