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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Y90 glass microspheres
The University of Arizona Cancer Center
Tucson, Arizona, United States
ACTIVE_NOT_RECRUITINGUniversity of California - Irvine
Orange, California, United States
RECRUITINGAdventHealth Radiation Oncology at Altamonte Springs
Altamonte Springs, Florida, United States
RECRUITINGMiami Cardiac and Vascular Institute at Baptist Hospital Miami
Miami, Florida, United States
RECRUITINGEmory University Hospital Midtown
Atlanta, Georgia, United States
RECRUITINGPiedmont Hospital
Atlanta, Georgia, United States
RECRUITINGNorthwestern University Memorial Hospital
Chicago, Illinois, United States
RECRUITINGUniversity of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
RECRUITINGUniversity of Iowa Health Care
Iowa City, Iowa, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
ACTIVE_NOT_RECRUITING...and 12 more locations
Overall response rate (ORR)
The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Time frame: 6 months
Duration of response (DoR)
DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Time frame: 6 months
Incidence of adverse events (AEs)
Incidence of AEs, grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity.
Time frame: 12 months
Incidence of serious adverse events (SAEs)
Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
Time frame: 12 months
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