65 Participants Needed

Combined Y-90 SIRT + SBRT for Liver Cancer

CA
Overseen ByCancer AnswerLine
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of Y-90 SIRT and SBRT safe for liver cancer treatment?

Yttrium-90 selective internal radiation therapy (Y-90 SIRT) has been used safely in treating liver cancers like hepatocellular carcinoma and intrahepatic cholangiocarcinoma, with safety confirmed over two decades of clinical use. It is important to have a multidisciplinary team to manage the treatment and monitor for any adverse reactions or complications.12345

What makes the Y-90 SIRT + SBRT treatment for liver cancer unique?

The Y-90 SIRT + SBRT treatment is unique because it combines selective internal radiation therapy (SIRT) with Yttrium-90, which targets liver tumors directly through the bloodstream, with stereotactic body radiation therapy (SBRT), a precise form of external radiation. This combination aims to enhance the effectiveness of treatment by delivering high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissue.24678

What data supports the effectiveness of this treatment for liver cancer?

Research shows that selective internal radiation therapy (SIRT) with yttrium-90 can improve outcomes for patients with inoperable liver cancer, including hepatocellular carcinoma (HCC). In one case, a patient with HCC experienced a dramatic response to SIRT after other treatments failed, highlighting its potential effectiveness.7891011

Who Is on the Research Team?

KC

Kyle C. Cuneo

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with unresectable hepatocellular carcinoma (liver cancer) that meets specific imaging criteria, has a life expectancy of at least 6 months, and agrees to use contraception. It excludes those who can't stay still for scans, are pregnant or refuse birth control, have certain allergies or contraindications to MRI contrast agents or Theraspheres, high bilirubin levels, main portal vein occlusion, excessive lung shunting from the liver.

Inclusion Criteria

Patients must have a life expectancy of at least 6 months.
I agree to use effective birth control during and for 3 months after the study.
I do not have untreated cancer outside of my liver.
See 5 more

Exclusion Criteria

My main portal vein is blocked.
Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)
My bilirubin levels did not significantly increase after Y90 treatment.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Y-90 SIRT Treatment

Participants receive Y-90 Selective Internal Radiation Therapy (SIRT) to deliver radiation internally to the tumor

1 week
1 visit (in-person)

SBRT Treatment

Participants receive Stereotactic Body Radiation Therapy (SBRT) targeting areas of tumors not fully treated by Y-90 SIRT

1-2 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of overall survival and progression

Up to 5 years
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • PET/CT
  • Selective Internal Radiation Therapy
  • Stereotactic Body Radiation Therapy
  • Yttrium-90
Trial Overview The study tests combining Y-90 Selective Internal Radiation Therapy (SIRT) with Stereotactic Body Radiation Therapy (SBRT) in treating liver cancer. This approach is being evaluated for safety and side effects; it's also the first time Y-90 PET/CT imaging will be used in planning SBRT.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Y-90 SIRT followed by SBRTExperimental Treatment5 Interventions

Yttrium-90 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Y-90 for:
🇪🇺
Approved in European Union as Y-90 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

Department of Health and Human Services

Collaborator

Trials
240
Recruited
944,000+

Published Research Related to This Trial

In a study of 105 patients with hepatocellular carcinoma (HCC) who underwent Yttrium-90 (Y90) radiation segmentectomy, specific tumour dose thresholds were identified that significantly predicted objective tumour response, with a maximum dose of 748 Gy and a mean dose of 568 Gy being particularly notable.
Patients receiving a mean tumour dose of at least 250 Gy had a median overall survival of 43.67 months, compared to 17.87 months for those receiving lower doses, indicating that higher doses correlate with improved survival outcomes.
Determination of tumour dose response threshold and implication on survival in patients with HCC treated with Y90 radiation segmentectomy: a simple semi-quantitative analysis.Cheng, B., Sethi, I., Villalobos, A., et al.[2023]
In a study involving 30 patients with unresectable hepatocellular carcinoma (HCC) and portal vein thrombosis, yttrium-90 therapy demonstrated a median overall survival of 13 months and a time to progression of 9 months, indicating its potential efficacy.
The therapy was generally safe, with only 13% of patients experiencing significant hepatobiliary toxicity and no serious complications like radiation pneumonitis or procedure-related mortality, suggesting it is a viable treatment option for this patient population.
Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis.Kokabi, N., Camacho, JC., Xing, M., et al.[2022]
A 54-year-old woman with multifocal hepatocellular carcinoma showed a dramatic clinical and radiological response after receiving selective internal radiation therapy (SIRT) with yttrium-90 microspheres, 9 weeks post-treatment.
This case highlights the potential effectiveness of SIRT as a treatment option for patients with hepatocellular carcinoma, especially after previous treatments have failed.
Dramatic response to selective internal radiation therapy for unresectable hepatocellular carcinoma.Park, WD., Li, BT., Maher, R., et al.[2020]

Citations

Determination of tumour dose response threshold and implication on survival in patients with HCC treated with Y90 radiation segmentectomy: a simple semi-quantitative analysis. [2023]
Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. [2022]
Dramatic response to selective internal radiation therapy for unresectable hepatocellular carcinoma. [2020]
To 1000 Gy and back again: a systematic review on dose-response evaluation in selective internal radiation therapy for primary and secondary liver cancer. [2022]
Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022]
[Chinese expert consensus on selective internal radiation therapy with yttrium-90 for primary and metastatic hepatocellular carcinoma]. [2021]
Selective internal radiation therapy with SIR-Spheres in hepatocellular carcinoma and cholangiocarcinoma. [2020]
Outcomes and Predictors of Toxicity after Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres for Unresectable Hepatocellular Carcinoma. [2020]
Is there a role for Ytrrium-90 in the treatment of unresectable and metastatic intrahepatic cholangiocarcinoma? [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Yttrium-90 Radiation Segmentectomy in Oligometastatic Secondary Hepatic Malignancies. [2023]
Selective intraarterial radionuclide therapy with Yttrium-90 (Y-90) microspheres for unresectable primary and metastatic liver tumors. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security