Single-cell Sequencing of Bronchoalveolar Lavage Fluid to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
A multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.
详细描述
This study is a multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written informed consent;
- •NSCLC patients who have been clinically diagnosed with RP or CIP after histopathologically confirmed radiotherapy or immunocheckpoint inhibitor treatment and have not received glucocorticoid or other drugs.
- •≥18 years old, less than 75 years old;
- •ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
- •Patients without contraindications to alveolar lavage;
排除标准
- •Poor patient compliance and violation of test regulations;
- •Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
- •Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
- •Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
- •Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
- •Untreated patients with chronic hepatitis B, HBV carriers with HBV DNA≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA & LT; 500 IU/mL), patients with cured hepatitis C could be enrolled;
- •Known history of HIV infection;
- •Received any other investigational drug or participated in any other clinical trial within 28 days.
研究组 & 干预措施
Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis
Single-cell Sequencing of BLF is detected before treatment, and then patients will receive the treatment of Radiation Pneumonitis according to the result.
干预措施: single-cell sequencing (Genetic)
Single-cell Sequencing of BLF to Guide the Treatment of Immune Checkpoint Inhibitor Pneumonitis
Single-cell Sequencing of BLF is detected before treatment, and then patients will receive the treatment of Immune Checkpoint Inhibitor Pneumonitis according to the result.
干预措施: single-cell sequencing (Genetic)
结局指标
主要结局
Response rate
时间窗: 8 weeks
Tumor diameter is measured before and 8 weeks after treatment. Area alleviated by lung shadow or ground-glass changes more than 50% was significant; The alleviating area of lung shadow or ground-glass change was 20% \~ 50%. Area alleviated by shadow or ground-glass changes in lung after treatment. 20% or worse than before treatment is ineffective.
次要结局
未报告次要终点
研究者
Jianguo Sun
Deputy director of oncology department, Clinical Professor
Xinqiao Hospital of Chongqing