The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors.in Real-world Clinical Practice: a Multicenter, Prospective, Open, Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.
研究概览
简要总结
The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.
详细描述
- Incidence of acute radiation pneumonitis (aRPs) in in patients with prior receipt of immune checkpoint inhibitors.
- Risk factors (especially analysis of the dosimetric risk factor) which may affect the product of aRPs events.
- Establish a model to predict aRPs and guide clinical treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed malignant tumor
- •Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy
排除标准
- •Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy
- •Non-thoracic radiotherapy patients
结局指标
主要结局
Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.
时间窗: 6 months after last-patient- radiation
All suspected diagnoses of pneumonitis (regardless of grade) were centrally reviewed by a multidisciplinary committee consisting of at least one radiologist, pulmonologist, and oncologist. CT (or PET-CT) imaging was reviewed for each patient, which was then compared to the radiation treatment plan; other causes such as infection or tumor progression had to be ruled out using the appropriate workup.
次要结局
未报告次要终点
研究者
HAN GUANG
Clinical Professor
Hubei Cancer Hospital