REGULUS: MRI-guided Adaptive SABR for Liver Cancers

NCT07223307 | Recruiting Phase 2 FDA Device

• 1 other identifier: IRB-82587
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Cancer; Intrahepatic Cholangiocarcinoma; Liver Metastases; HCC

Outcome Measures

Primary Outcomes (1)

• 1-year Overall Survival (OS)

  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.

  1 year after SABR

Secondary Outcomes (7)

• Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events

  Within 90 days of completing SABR

• Rate of Grade ≥ 2 Radiation Pneumonitis

  Within 90 days of completing SABR

• Rate of Grade ≥ 2 Chest Wall Toxicity

  Within 90 days of completing SABR

• Change from Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score up to 1 Year Post-SABR

  Up to 1 year post-SABR

• Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR

  Up to 1 year post-SABR

Study Arms (1)

MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)

EXPERIMENTAL

Participants will receive a single fraction of MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) using the MRIdian system. Treatment includes daily adaptive planning based on MRI to optimize dose delivery to the tumor and minimize dose to surrounding normal tissue. Eovist contrast is administered before treatment to enhance visualization. Patients perform an inspiratory breath hold during radiation delivery to minimize motion.

Radiation: MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)

Interventions

MRI-guided adaptive stereotactic ablative body radiotherapy (SABR) RADIATION

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.

MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Stanford University: lead
• Viewray Inc.: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Eleanor Brown

CONTACT

650-497-8966; eleanor9@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 31, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)