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A Study Evaluating the Safety and Efficacy of Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres to Bridge or Downstage Patients With Hepatocellular Carcinoma (HCC) to Liver Transplant or Resection and Elicit Pathologic Necrosis.

NCT07663487 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-06-25

No results posted yet for this study

Summary

This clinical investigation involves the use of an approved medical device (SIR-Spheres®) for a new purpose in patients with certain types of liver cancer. The goal is to determine whether this treatment can help patients qualify for or maintain eligibility for a liver transplant. Participation is completely voluntary and will not affect your standard medical care. The main risks involve possible side effects related to the use of radiation in the liver, such as fatigue, abdominal pain, nausea, or changes in liver function. You may or may not benefit personally from participating in this study, but the results may help improve future treatment for others.

Your doctor is inviting you to take part in this clinical investigation because you have been diagnosed with liver cancer. Your doctors will have decided that treatments designed to remove or destroy cancer completely, such as surgery or heat treatment, are not suitable for you.

This clinical investigation is focused on testing how well selective internal radiation therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres ("SIR-Spheres") work, its potential benefits, its safety, and finding out if there are any bad effects when it's used like it's supposed to be used. For more information, please see the section on the purpose of the clinical investigation.

This Patient Informed Consent Form (PIC) tells you about the clinical investigation. It explains the tests and treatments involved and how your information will be used. Knowing what is involved will help you decide if you want to take part in the clinical investigation.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DEVICE

SIR-Spheres Selectively Delivered to Liver Tumor

SIRT involves the following two procedural components: 1. Embolization: Injection into the distal arterial tumor feeding vessels of microspheres (SIR-Spheres), which act as the delivery vehicle for the therapeutic moiety Y-90, and 2. Irradiation: Once located in the distal microvasculature of the tumor, SIRSpheres deliver high dose beta irradiation to the tumor microvascular plexus and to tumor cells directly.

Sponsors & Collaborators

  • Sirtex Medical

    lead INDUSTRY

Principal Investigators

  • David Wootten, PhD · Sirtex Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-10-31
Completion
2029-10-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663487 on ClinicalTrials.gov