REGULUS: MRI-guided Adaptive SABR for Liver Cancers

Not Applicable

Not yet recruiting

• Conditions: Liver Cancer; Intrahepatic Cholangiocarcinoma; Liver Metastases; HCC

• Registration Number: NCT07223307
• Lead Sponsor: Stanford University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-28
• Last Update Submitted: 2025-10-28
• Study First Posted: 2025-10-31
• Last Update Posted: 2025-10-31
• Study Start: 2025-12-01
• Primary Completion: 2030-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Rate of Grade ≥ 2 Gastrointestinal (GI) Adverse Events	Within 90 days of completing SABR	Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 gastrointestinal adverse events (including fatigue, nausea, diarrhea, or GI pain) attributable to SABR.
Rate of Grade ≥ 2 Radiation Pneumonitis	Within 90 days of completing SABR	Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 radiation pneumonitis attributable to SABR.
Rate of Grade ≥ 2 Chest Wall Toxicity	Within 90 days of completing SABR	Proportion of participants experiencing CTCAE v5.0 grade ≥ 2 chest wall toxicity attributable to 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	Patient-reported global health status and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).; Scores range from 0 to 100, with higher scores indicating better global health status and overall quality of life.
Change from Baseline in FACT-Hep Total Score up to 1 Year Post-SABR	Up to 1 year post-SABR	Patient-reported quality of life will be evaluated using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire.; The FACT-Hep consists of the FACT-General (FACT-G) plus additional hepatobiliary-specific items.; Total scores range from 0 to 180, with higher scores indicating better health-related quality of life.
Change from Baseline in COST-FACIT Total Score up to 1 Year Post-SABR	Up to 1 year post-SABR	Financial toxicity will be assessed using the Comprehensive Score for Financial Toxicity (COST-FACIT) questionnaire.; Scores range from 0 to 44, with higher scores indicating lower financial toxicity (better financial well-being).
Rate of Patients With Total Delivery Time > 120 Minutes	Baseline	Percentage of patients with total SABR delivery time exceeding 120 minutes.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States