NCT07223307 REGULUS: MRI-guided Adaptive SABR for Liver Cancers
| NCT ID | NCT07223307 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2026-01-23 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2026-01-23 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07223307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07223307 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07223307 currently recruiting?
Yes, NCT07223307 is actively recruiting participants. Contact the research team at eleanor9@stanford.edu for enrollment information.
Where is the NCT07223307 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT07223307 clinical trial?
NCT07223307 is sponsored by Stanford University. The trial plans to enroll 62 participants.
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