NCT07223307RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
Single arm unblinded study of simulation-free MRI-guided SABR with adaptive replanning in one session for treatment of patients with liver cancers
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 23 Oct 2025
- Start date
- 23 Jan 2026
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- Stanford University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07223307
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 62
- From 23 Jan 2026 to the primary completion date, 31 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with radioembolization
- Cytotoxic chemotherapy or investigational agent within 1 week of SABR
- Prior radiotherapy overlapping with study treatment site
Other illness
- Presence of a pacemaker or other implanted cardiac device
Other
- Female patients who are pregnant
- Contraindication to having an MRI scan or inability to tolerate MRI
- Direct tumor extension into the stomach, duodenum, small bowel or large bowel
- Patient unable to breath hold \> 15 seconds
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.