Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.

Official Title
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Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

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

Intervention / Treatment
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* Device: Eye90 Microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI). Must have at least one lesion > 2 cm within the target perfused volume. At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST. Total linear length of all lesions must be ≤ 9 cm. Must have preservation of >700cc of normal liver parenchyma outside of treated volume. Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT. No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed. Life expectancy of ≥ 6 months. ≥ 18 years old. Exclusion Criteria: Hemoglobin ≤ 85 mg/L. Platelet count < 50,000/microliter or prothrombin (PT) activity > 50% normal INR > 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures). ALT > 2.5x upper limit AST > 2.5x upper limit For HCC subjects, Bilirubin ≥ 2 mg/dL. For mCRC subjects, Bilirubin ≥ 1.2 mg/dL. eGFR ≤ 60 mL/min/1.73 m2. Portal vein thrombosis (PVT). Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater Estimated lung dose > 30 Gy as calculated using the lung shunt % 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
Interventional Model Description: Open Label
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of toxicity | Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 | 6 months | 
| Incidence of TESAEs | Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 | 6 months | 
| Overall Response Rate (ORR) by RECIST 1.1 | ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline | 6 months | 
| Overall Response Rate (ORR) by mRECIST | ORR is defined at Complete or Partial Response using local mRECIST compared to baseline | 6 months | 

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