jRCT2031220410进行中（未招募）不适用
A phase II study of boron neutron capture therapy (BNCT) for patients with unresectable angiosarcoma, by using CICS-1 and SPM-011
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 89age old under（—）
- 性别
- All
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 (RECIST v1.1)
次要结局
未报告次要终点
研究者
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