An interventional study of Yttrium-90, Selective Internal Radiation Therapy and Stereotactic Body Radiation Therapy in Liver Malignancy, sponsored by University of Michigan Rogel Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Treatment
This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.
Selective Internal Radiation Therapy (SIRT) is a technique where radiation is internally delivered to a tumor. In SIRT, small radioactive beads are deposited in the liver through a large blood vessel (hepatic artery). SIRT that uses the radioactive material Yttrium-90 is called Y-90 SIRT.
Stereotactic Body Radiation Therapy (SBRT) is a technique where radiation is externally delivered to a tumor. In SBRT, a machine produces a beam of radiation that targets the tumor from outside the body.
After receiving Y-90 SIRT, participants will be evaluated to estimate how much radiation was absorbed by their tumors during Y-90 SIRT. Y-90 PET-CT imaging will be used to help plan SBRT, which will target areas of tumors that did not receive as much radiation as expected during Y-90 SIRT.
Updated to add 5 patients to enrollment goal to achieve desired number of evaluable patients
Since patients treated with Y-90 for any liver malignancy can benefit from the Y-90+SBRT combined treatment approach we have decided to open up the protocol to all eligible patients and not HCC alone.
University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following:
Metastatic liver cancer is defined as having:
o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease
Exclusion Criteria:
Contraindication to Theraspheres
Y-90 SIRT followed by SBRT
Device: Yttrium-90, Selective Internal Radiation Therapy · Radiation: Stereotactic Body Radiation Therapy
Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT); SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres This combination listing incorporates appropriately as a combination product what was previously listed as a drug (Y-90) and two devices (SIRT and Theraspheres).
Also known as: Y-90
3-5 fractions over 1-2 weeks, after Y-90 SIRT
Also known as: SBRT
Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline
The primary safety endpoint is the binary indicator for a CTP increase of 2 or more points within 6 months and relative to pre-SBRT baseline. An increase of 2 or more points indicates clinically significant liver decompensation.
Time frame: Up to 6 months after SBRT
Incidence of toxicities of grade 3 or higher
A secondary safety endpoint is grade 3+ toxicity within 6 months relative to pre-SBRT baseline. Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 6 months after SBRT
Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5
A secondary safety endpoint is the binary indicator for an increase in ALBI within 6 months relative to pre-SBRT baseline of 0.5 or greater.
Time frame: Up to 6 months after SBRT
Freedom from local progression (FFLP) at the lesion level
FFLP at the lesion level is defined as the time from SIRT to progression of a SBRT-treated lesion. Progression is defined based on RECIST and mRECIST criteria.
Time frame: Until progression or last surveillance scan at approximately 24 months after SBRT
Freedom from local progression (FFLP) at patient level
FFLP at the patient level is defined as the time from SIRT to progression of the treated lesions including those not targeted by SBRT. Progression is defined based on RECIST v1.1and mRECIST criteria.
Time frame: Until progression or last surveillance scan at approximately 24 months after SBRT
Response rate
Response rate defined per RECIST v1.1 and mRECIST criteria and categorized as follows: progressive disease or stable disease = non-responder, partial response or complete response = responder.
Time frame: Up to 6 months after SBRT
Overall survival
Overall survival will be calculated as the time from Y-90 SIRT treatment to death from any cause, or until patient's last follow-up visit, or until study stops.
Time frame: up to approximately 2 years.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Michigan Rogel Cancer Center