Clinical Research on Efficacy and Safety of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma：A Prospective，Single-arm, Open-label, Multi-center Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide for stage 4/M neuroblastoma.
详细描述
This study is a prospective, single-arm, open-lable, multi-center clinical trial. Children≤ 14 years old are eligible for this study if they were newly diagnosed with neuroblastoma and assessed as stage 4 according to the International Neuroblastoma Staging System (INSS) or stage M according to the International Neuroblastoma Risk Group (INRG) respectively. Patients enrolled in this study will receive combined induction chemotherapy with arsenic trioxide following an modifed protocol based on N7 and NB2004 protocols. Objective response rate (ORR) at 4 weeks after completing induction chemotherapy was defined as the main outcome and adverse events were monitored and graded in the meantime.
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
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System（INSS) or the International Neuroblastoma Risk Group (INRG) staging system;
- •Patients not more than 14 years old;
- •There are measurable lesions;
- •Guardians agreed and signed informed consent.
排除标准
- •Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy.
- •Patients with one or more critical organs failure such as heart, brain, kidney failure.
研究组 & 干预措施
ATO-combined chemotherapy
Patients receive combined induction chemotherapy with arsenic trioxide.
干预措施: Arsenic Trioxide (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Four weeks after ATO-combined induction chemotherapy
The percentage of patients who had complete remission（CR）or partial remission（PR）after induction chemotherapy combined ATO. Per Response Evaluation Criteria In Solid Tumors Criteria (WHO criteria) for target lesions and assessed by MRI or CT: CR: All lesions completely disappear, maintained for at least 4 weeks. PR: Estimated tumor size reduction by more than 50%, maintained for at least 4 weeks.
次要结局
- Overall Survival Rate(3 years.)
- Progression Free Survival Rate(3 years.)
- Number of Participants With Adverse Events(From date of ATO-combined chemotherapy until the date of first documented adverse event, and follow up for 3 years.)
研究者
Yang Li
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University