NCT06932861尚未招募1 期
Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
Xinxin Zhang0 个研究点目标入组 5 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- Adverse Event
研究概览
简要总结
An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;
- •Age ≥ 6 years;
- •No known effective treatment available or no treatment proven to prolong survival with an acceptable quality of life;
- •Expected survival time greater than 6 months;
- •ECOG performance status score of 0-1; -
排除标准
- •1.History of or concurrent with other untreated malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 2.History of or current active autoimmune diseases. 3.Has uncontrolled cardiovascular diseases.
研究组 & 干预措施
Vaccine arm
Experimental
干预措施: mRNA Tumor Vaccine Therapy (Biological)
结局指标
主要结局
Adverse Event
时间窗: From the first administration of the study drug until the occurrence of death, loss to follow-up, withdrawal of informed consent, initiation of a new anti-tumor therapy, or 21 days after the last dose, whichever comes first.
次要结局
未报告次要终点
研究者
Xinxin Zhang
Director, Department of Otorhinolaryngology - Head and Neck Surgery，Clinical Professor
Chinese PLA General Hospital
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