jRCT2031240246招募中不适用
Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment (SJ-BT001)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 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 85age old under（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained from the subject.
- •Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma)
- •Measurable disease, as defined by RECIST v1.
- •Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment.
- •Patients with ECOG performance status score of 0 or
- •Patients whose longest diameter sum of the lesions to be treated is 15 cm or less.
排除标准
- •Patients with active disease or active double cancers other than target lesions.
- •Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities
- •Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion.
- •Any serious concomitant disease that precludes completion of the study treatment.
- •Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field.
结局指标
主要结局
-
- Occurrence rate of dose-limiting toxicity - Response rate (RECIST v1.1)
次要结局
未报告次要终点
研究者
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