Back to search results

Combined Y-90 SIRT and SBRT for Liver Cancer

This study is looking at a new way to treat liver cancer by combining two established radiation therapies: Yttrium-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT uses tiny radioactive beads delivered directly to the liver tumor, while SBRT uses external radiation beams. The study aims to see how safe and effective this combined approach is. You may be able to join if you are 18 or older and have unresectable hepatocellular carcinoma or metastatic liver cancer. Researchers will measure side effects and changes in your liver health for up to six months after SBRT. The study is currently recruiting 70 participants.

Study design
This is an interventional study with a planned enrollment of 70 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive Y-90 SIRT on day 0, followed by a PET/CT scan within 3 hours. Then, you will receive SBRT over 3-5 fractions during 1-2 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your liver health and side effects will be monitored for up to 6 months after SBRT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04518748

Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~70 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Yttrium-90Selective Internal Radiation TherapyStereotactic Body Radiation TherapyPET/CTTherasphere

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline
Measured over Up to 6 months after SBRT
+2 more outcomes measured

Conditions

Liver Malignancy

Explore related trials

Hepatocellular CarcinomaLiver Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Kyle Cuneo, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following:
Biopsy proven hepatocellular carcinoma (HCC); or
A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria.
Patients must not have known untreated or progressive disease outside of the liver
At least one lesion \>2 cm diameter or 4 cc volume
Patients must have a life expectancy of at least 6 months.
Patients must be 18 years of age or older
All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment.
Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion

Inability to lie still for imaging studies (e.g. PET/CT)
Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction.
Patients with known allergy or contraindication to intravenous iodinated contrast agents
Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)
Contraindication to Theraspheres
Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.
Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis;
Bilirubin \>2.0 at baseline
Occlusion of the main portal vein
Contraindication to radiation therapy
Note: Patients who have an increase in bilirubin \>1.0 from the time of Y90 to SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.

What this trial measures

  • Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baselineUp to 6 months after SBRT

    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.

  • Incidence of toxicities of grade 3 or higherUp to 6 months after SBRT

    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.

  • Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5Up to 6 months after SBRT

    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.