NCT06836492招募中3 期
A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.
Yizhuo Zhang1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The objective response rate (ORR)
研究概览
简要总结
The purpose is to explore the efficacy and safety of the SYSUCC-RMS regimen for pediatric RMS patients and to explore the impact of concurrent radiotherapy and chemotherapy on the survival rate of low-risk, medium risk, high-risk, and extremely high-risk patients in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •0 years < age < 18 years old, regardless of gender;
- •Tumor patients diagnosed by histopathology or bone marrow cytology;
- •Patients are treated for the first time;
- •ECoG score ≤ 2;
- •The expected survival time is more than 8 months;
- •Patient's parent or guardian signs informed consent.
排除标准
- •Combined with immunodeficiency disease
- •Second tumor
结局指标
主要结局
The objective response rate (ORR)
时间窗: Up to 1 year
The ORR was calculated based on the best overall response.
disease control rate (DCR)
时间窗: Up to 1 year
progression-free survival (PFS)
时间窗: Up to 10 years
Furthermore, we provided Kaplan-Meier plots for PFS
overall survival (OS)
时间窗: Up to 10 years
Furthermore, we provided Kaplan-Meier plots for OS.
次要结局
- The safety of the SYSUCC-RMS regimen for pediatric RMS patients.(Up to 10 years)
研究者
Yizhuo Zhang
Sun Yat-sen University Cancer Center
Sun Yat-sen University
研究点 (1)
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