Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (NCT04736121)
A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University of California Los Angeles - Ronald Reagan Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- University of California Los Angeles - Ronald Reagan Medical Center — Los Angeles, California
- Providence St. Joseph Hospital — Orange, California
- University of California Irvine — Orange, California
- Miami Cardiac and Vascular Institute at Baptist Hospital — Miami, Florida
- Sarasota Memorial Health Care System — Sarasota, Florida
- Emory University Hospital Midtown — Atlanta, Georgia
- University of Kansas Medical Center — Kansas City, Kansas
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Columbia University CUIMC/NYPH — New York, New York
- University of North Carolina - Chapel Hill Medical Center — Chapel Hill, North Carolina
- Wake Forest Baptist Health — Winston-Salem, North Carolina
- University of Cincinnati Cancer Center CTO — Cincinnati, Ohio
- The Cleveland Clinic Foundation — Cleveland, Ohio
- Hospital of the University Pennsylvania — Philadelphia, Pennsylvania
- Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania
- Rhode Island Hospital — Providence, Rhode Island
- Clinical Research Institute and Methodist Hospital — Dallas, Texas
- University of Texas Health Science Center at Houston — Houston, Texas
- UT MD Anderson Cancer Center — Houston, Texas
- The University of Vermont Medical Center — Burlington, Vermont
- Inland Imaging — Spokane, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Unresectable Hepatocellular Carcinoma
- A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab — Innsbruck,
- Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells — Basking Ridge, New Jersey
- An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery — Baltimore, Maryland
- Atezolizumab+Bevacizumab+SBRT in Unresectable HCC — Boston, Massachusetts
Explore by condition: All Unresectable Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.