Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of toxicity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 m
- •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.
结局指标
主要结局
Incidence of toxicity
时间窗: 6 months
Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Overall Response Rate (ORR) by mRECIST
时间窗: 6 months
ORR is defined at Complete or Partial Response using local mRECIST compared to baseline
Incidence of TESAEs
时间窗: 6 months
Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Overall Response Rate (ORR) by RECIST 1.1
时间窗: 6 months
ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline
次要结局
未报告次要终点