Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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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.

Official Title
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Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer

Intervention / Treatment
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* Device: EYE90 Microspheres Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EYE90 Microspheres Treatment<br>Radioembolization with Eye90 Microspheres | Device: EYE90 Microspheres Treatment<br>* Y90 glass microspheres<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review. | 6 months | 
| Duration of response (DoR) | DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR | 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. | 12 months | 
| Incidence of serious adverse events (SAEs) | Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Liver Cancer, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres