Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 42
- 主要终点
- Duration of response (DoR)
研究概览
简要总结
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.
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
- •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
排除标准
- •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.
研究组 & 干预措施
EYE90 Microspheres Treatment
Radioembolization with Eye90 Microspheres
干预措施: EYE90 Microspheres Treatment (Device)
结局指标
主要结局
Duration of response (DoR)
时间窗: 6 months
DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Overall response rate (ORR)
时间窗: 6 months
The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Incidence of adverse events (AEs)
时间窗: 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)
时间窗: 12 months
Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
次要结局
未报告次要终点