REGULUS: MRI-guided Adaptive SABR for Liver Cancers

This study is testing a new way to deliver radiation therapy called MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) for people with liver cancer, intrahepatic cholangiocarcinoma, or liver metastases. This treatment uses an MRI machine to guide the radiation and adjust the plan daily to precisely target the tumor. The study aims to see how many people are still alive one year after receiving this treatment. You may be able to join if you are 18 years or older and have a confirmed diagnosis of one of these liver cancers. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all 62 participants will receive the same treatment. It is unblinded, so both you and your doctors will know what treatment you are receiving.
What's involved
You will receive a single session of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR). This treatment includes daily MRI imaging to update the radiation plan.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured one year after receiving the SABR treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223307

REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Recruiting
PHASE2Ages 18+InterventionalTreatment
Stanford University
~62 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1-year Overall Survival (OS)
Measured over 1 year after SABR
Liver Cancer
Intrahepatic Cholangiocarcinoma
Liver Metastases
HCC

NCT07223307

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Palo Alto, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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
  • 1-year Overall Survival (OS)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.