jRCT1080224974已完成1 期
Phase 1 clinical trial of Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for Malignant melanoma and angiosarcoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Single-center, open label, single armed study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •1.Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
- •2.Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
- •3.Patients with lesions that are 6 cm or less from the skin surface to the deepest part of the tumor
- •4.Patients with lesions in the head, neck, chest, or extremities
- •5.Patients who do not have apparent abnormal values in the latest screening test within 28 days of registration
排除标准
- •1.Patients with obvious disseminated lesions
- •2.Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
- •3.Patients with active lesions / active multiple cancers in addition to the target lesion
- •4.Patients with infections that require systemic treatment.
- •5.Patients with active implantable medical devices
- •Patients with a history of BNCT treatment
结局指标
主要结局
safety
时间窗: study period
- Evaluate the safety of each dose level from the frequency of DLT occurrence - Evaluate the incidence of adverse events and failures during the study period
次要结局
- Tumor shrinkage rate
- Progression-free survival
研究者
研究点 (1)
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