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Liver MalignancyNCT04518748

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

A study testing Yttrium-90, Selective Internal Radiation Therapy and Stereotactic Body Radiation Therapy in people with Liver Malignancy, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Malignancy
What is being tested?
Yttrium-90, Selective Internal Radiation Therapy and Stereotactic Body Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
16 Sep 2020to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
  • Patients must not have known untreated or progressive disease outside of the liver
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

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.

Read the detailed description

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.

Being tested
Yttrium-90, Selective Internal Radiation Therapy, Stereotactic Body Radiation Therapy
Keywords
Ytrium-90 (Y-90), Selective Internal Radiation Therapy (SIRT), Stereotactic Body Radiation Therapy (SBRT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yttrium-90, Selective Internal Radiation TherapyDevice

    Also called Y-90

    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).

  • Stereotactic Body Radiation TherapyRadiation

    Also called SBRT

    3-5 fractions over 1-2 weeks, after Y-90 SIRT

Study groups in NCT04518748
Study groupRoleWhat they receive
Y-90 SIRT followed by SBRTExperimentalY-90 SIRT followed by SBRT
Receives: Device: Yttrium-90, Selective Internal Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months after SBRT

  2. 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.

    Measured: Up to 6 months after SBRT

  3. 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.

    Measured: Up to 6 months after SBRT

Secondary outcomes (4)

  1. 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.

    Measured: Until progression or last surveillance scan at approximately 24 months after SBRT

  2. 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.

    Measured: Until progression or last surveillance scan at approximately 24 months after SBRT

  3. 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.

    Measured: Up to 6 months after SBRT

  4. 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.

    Measured: up to approximately 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2020
  2. Study start16 Sep 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04518748
Sponsor's protocol ID
UMCC 2020.052
Other IDs
HUM00181352, R01EB022075
Status last verified
Sep 2026
First submitted
14 Aug 2020
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Lu Z, Polan DF, Wei L, Aryal MP, Fitzpatrick K, Wang C, Cuneo KC, Evans JR, Roseland ME, Gemmete JJ, Christensen JA, Kapoor BS, Mikell JK, Cao Y, Mok GSP, Dewaraja YK. PET/CT-Based Absorbed Dose Maps in 90Y Selective Internal Radiation Therapy Correlate with Spatial Changes in Liver Function Derived from Dynamic MRI. J Nucl Med. 2024 Aug 1;65(8):1224-1230. doi: 10.2967/jnumed.124.267421.

    PubMed 38960710

Questions about this trial

What is this clinical trial studying?

A study testing Yttrium-90, Selective Internal Radiation Therapy and Stereotactic Body Radiation Therapy in people with Liver Malignancy, run by University of Michigan Rogel Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline (time frame: Up to 6 months after SBRT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04518748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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