This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with unresectable Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
* No extra hepatic disease.
* Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
* Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume.
* Intent to treat all lesions within a single session.
* Hypervascular on CBCT, CT, or MRI.
* Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
* Life expectancy of ≥ 6 months.
* ≥ 18 years old at the time of informed consent
Exclusion Criteria:
* Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
* Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
* INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
* ALT \> 5x upper limit.
* AST \> 5x upper limit.
* Bilirubin ≥ 2.0 mg/dL.
* eGFR ≤ 50 mL/min/BSA.
* Macrovascular invasion.
* Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
* Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.
Primary outcome measure(s)
Overall response rate (ORR) — 6 months The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Duration of response (DoR) — 6 months DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Incidence of adverse events (AEs) — 12 months Incidence of AEs, grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity.
Incidence of serious adverse events (SAEs) — 12 months Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
Trial sites (22)
Facility
City
Region
Status
The University of Arizona Cancer Center
Tucson
Arizona
University of California - Irvine
Orange
California
AdventHealth Radiation Oncology at Altamonte Springs
Altamonte Springs
Florida
Miami Cardiac and Vascular Institute at Baptist Hospital Miami
Miami
Florida
Emory University Hospital Midtown
Atlanta
Georgia
Piedmont Hospital
Atlanta
Georgia
Northwestern University Memorial Hospital
Chicago
Illinois
University of Illinois Hospital and Health Sciences System
Chicago
Illinois
University of Iowa Health Care
Iowa City
Iowa
University of Louisville
Louisville
Kentucky
Ochsner Clinic Foundation
New Orleans
Louisiana
Beth Israel Deaconess
Boston
Massachusetts
University of Missouri - Ellis Fischel Cancer Center
Columbia
Missouri
SSM Health Saint Louis University
St Louis
Missouri
Weill Cornell Medicine-New York Presbyterian Hospital
New York
New York
Charlotte Radiology
Charlotte
North Carolina
Hospital of the University of Pennsylvania
Philadelphia
Pennsylvania
HCA Healthcare Research Institute (Sarah Cannon)
Nashville
Tennessee
University of Utah
Salt Lake City
Utah
Inland Imaging
Spokane
Washington
Froedtert Hospital/Medical College of Wisconsin
Milwaukee
Wisconsin
Vancouver Coastal Health Research Institution (VCHRI)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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