REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Recruiting now · Phase 2

Conditions studied: Liver Cancer, Intrahepatic Cholangiocarcinoma, Liver Metastases, HCC

In brief

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

Key facts

Study ID

NCT07223307

Run by

Stanford University

People needed

62

Starts

2026-01-23

Expected to finish

2030-01-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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