JPRN-jRCT2031220687招募中2 期
A safety, efficacy and pharmacokinetic study of SPJ-101CA as a maintenance therapy for newly diagnosed high risk neuroblastoma - SPJ-101CA for neuroblastoma
Makimoto Atsushi0 个研究点目标入组 16 人开始时间: 2023年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 1age old 至 < 18age old（—）
- 性别
- All
入选标准
- •(1) Aged between 1 and 18 years at the time of informed consent
- •(2) Histopathological diagnosis with neuroblastoma or ganglioneuroblastoma
- •(3) Stratified to high risk group according to International Neuroblastoma Risk Grouping system
- •(4) No progression after primary treatment including chemotherapy, high-dose chemotherapy with hematopoietic stem cell transplant and radiotherapy
- •(5) Within 100 days after the most recent anticancer therapy
- •(6) No severe organ damage to disturb protocol treatment
- •(7) No active infectious disease
- •(8) Written informed consent from the patient and/or the guardian
排除标准
- •(1) Continuing active anticancer treatments
- •(2) Concomitant malignancy
- •(3) Allergy to gelatin
- •(4) A female patient in pregnancy or possible pregnancy, or during breast feeding
- •(5) Concomitant psychiatric disorders
- •(6) Complications which would be an obstacle to observe the treatment protocol
- •(7) Inappropriate to be enrolled by investigators' judgement
研究者
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