Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer
Conditions
Keywords
Hepatocellular Carcinoma, Liver Cancer, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres
Brief summary
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.
Interventions
DEVICEEYE90 Microspheres Treatment
Y90 glass microspheres
Sponsors
ABK Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORAndrew Kennedy, MD
Director, Radiation Oncology Research at Sarah Cannon
PRINCIPAL_INVESTIGATORAmmar Sarwar, MD
Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center
STUDY_DIRECTORAravind Arepally, MD
ABK Biomedical, Inc
Outcome results
None listed