NCT04293289已完成不适用
Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
研究概览
简要总结
Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
- •Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
- •Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
- •Patients with lesions in the head, neck, chest, or extremities
- •Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration
排除标准
- •Patients with obvious disseminated lesions
- •Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
- •Patients with active lesions / active multiple cancers in addition to the target lesion
- •Patients with infections that require systemic treatment.
- •Patients with active implantable medical devices
- •Patients with a history of BNCT treatment
结局指标
主要结局
The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
时间窗: 90 days
Evaluate the safety at each dose level by the frequency of DLT occurrence
次要结局
- Progression-free period(30, 60, 90, 180 days)
- Tumor shrinkage ratio, tumor best shrinkage ratio(30, 60, 90, 180 days)
- Best response rate for target lesion(30, 60, 90, 180 days)
- Response rate(30, 60, 90, 180 days)
- Progression-free survival(30, 60, 90, 180 days)
- Survival length(30, 60, 90, 180 days)
- The incidence of adverse events and failures(180 days)
- Period until chronic adverse event(30, 60, 90, 180 days)
研究者
研究点 (2)
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