NCT05601232进行中（未招募）2 期
A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
研究概览
简要总结
The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained from the subject.
- •Histologically documented primary skin angiosarcoma.
- •Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual refuses treatment.)
- •Measurable disease, as defined by RECIST v1.
- •The longest diameter of the entire target lesion is 15 cm or less.
- •ECOG performance status score of Grade 0 to 2
排除标准
- •Apparent disseminated tumor lesions.
- •Hereditary fructose intolerance.
- •Phenylketonuria.
- •Any serious concomitant disease that precludes completion of the study treatment.
- •The target lesion has received radiation exceeding 75 Gy.
结局指标
主要结局
Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Baseline until Day90
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
次要结局
- Response rate as assessed by the investigator according to RECISTv1.1(Baseline until Day90)
- Duration of response as assessed by the IRF and the investigator(Baseline until disease progression or death)
- Locoregional progression-free survival as assessed by the investigator(Baseline until in-field disease progression)
- Time to response as assessed by the IRF(Baseline until the initial occurrence of CR or PR)
- Complete response (CR) rate as assessed by the IRF and the investigator(Baseline until the initial occurrence of CR)
- Disease control rate as assessed by the IRF and the investigator(Baseline until the initial occurrence of CR, PR or SD)
- Extra-regional relapse-free survival as assessed by the investigator(Baseline until extra-field disease progression)
- Progression-free survival as assessed by the IRF and the investigator(Baseline until disease progression or death)
- Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator(Baseline until Day90)
- Overall survival(Baseline until death)
- Overall response rate as assessed by the IRF and the investigator(Baseline until the initial occurrence of CR or PR)
研究者
研究点 (1)
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