Recruiting
Phase 2

SABR

Sponsor:

Stanford University

Code:

NCT07223307

Conditions

Liver Cancer

Intrahepatic Cholangiocarcinoma

Liver Metastases

HCC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)

Study Details

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

Study ID

NCT07223307

Start date

Jan 23, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MRI-guided Adaptive Stereotactic Ablative Body Radiotherapy (SABR)

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.

Interventions

MRI-guided adaptive stereotactic ablative body radiotherapy (SABR)

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.

Primary outcome measure

  • 1-year Overall Survival (OS) [ Time Frame: 1 year after SABR ]

Central Contacts and Locations

Central contacts

Eleanor Brown

650-497-8966eleanor9@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Eleanor Brown

650-497-8966eleanor9@stanford.edu

Principal Investigator:

Erqi L Pollom, MD

More Information

Sponsor

Stanford University

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-09.