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Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
NCT04736121 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2, maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver function and good performance status. It is also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of Floxuridine (FUDR).
Conditions Studied
Interventions
- DEVICE Resin microspheres containing yttrium-90 (Y-90)
Study Locations (20)
California
- University of California Los Angeles - Ronald Reagan Medical Center — Los Angeles
- Providence St. Joseph Hospital — Orange
- University of California Irvine — Orange
Texas
- Clinical Research Institute and Methodist Hospital — Dallas
- University of Texas Health Science Center at Houston — Houston
- UT MD Anderson Cancer Center — Houston
Florida
- Miami Cardiac and Vascular Institute at Baptist Hospital — Miami
- Sarasota Memorial Health Care System — Sarasota
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
North Carolina
- University of North Carolina - Chapel Hill Medical Center — Chapel Hill
- Wake Forest Baptist Health — Winston-Salem
Ohio
- University of Cincinnati Cancer Center CTO — Cincinnati
- The Cleveland Clinic Foundation — Cleveland
Pennsylvania
- Hospital of the University Pennsylvania — Philadelphia
- Allegheny-Singer Research Institute — Pittsburgh
Georgia
- Emory University Hospital Midtown — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2026-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04736121
The ClinicalTrials.gov registry entry for NCT04736121 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sirtex Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Unresectable Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which Resin microspheres containing yttrium-90 (Y-90) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04736121 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04736121 about?
NCT04736121 is a clinical study titled "Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients". The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C. SIR-Spheres consist of biocompatible resin...
What is the current status of trial NCT04736121?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-05-28. Estimated completion is 2026-09.
What conditions does trial NCT04736121 study?
This clinical trial studies the following conditions: Unresectable Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, BCLC Stage A Hepatocellular Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04736121?
The interventions under investigation include: Resin microspheres containing yttrium-90 (Y-90) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04736121?
This trial is sponsored by Sirtex Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04736121 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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