NCT05899725已完成不适用
The Efficacy and Safety of Corticosteroids in Combination With Biological Agents in the Management of Severe Immune Related Adverse Events Cohort A: The Efficacy and Safety of Corticosteroids or Corticosteroids Combination With Ruxolitinib in Patients With Severe Checkpoint Inhibitor Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
研究概览
简要总结
This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old≤ Aged ≤80 years old.
- •Diagnosis of malignancy.
- •Malignant tumors initially treated with immune checkpoint inhibitors (antibodies targeting PD-1, PD-L1, CTLA-4, or new immune checkpoint inhibitors) in combination with or without chemotherapy.
- •Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or
- •Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent.
排除标准
- •Predicted life expectancy<12 weeks.
- •Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment.
- •malignancy progression.
- •Patients with other serious complications that may affect safety or adherence judged by the investigator.
- •Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.
- •Patients can't fully understand the study protocol, arrangement and other study-related elements.
- •Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.
- •Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion.
- •Patients who cannot comply with study treatment and follow-up according to the trial protocol.
研究组 & 干预措施
Cohort 1: severe CIP with the treatment of corticosteroids
Active Comparator
severe CIP with the treatment of corticosteroids
干预措施: Corticosteroids (Drug)
Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib
Experimental
severe CIP with the treatment of corticosteroids and Ruxolitinib
干预措施: Corticosteroids and Ruxolitinib (Drug)
结局指标
主要结局
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
时间窗: 8 weeks
Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
次要结局
- Mortality(8 weeks)
- Proportion of invasive ventilator assisted respiration(8 weeks)
- Incidence of pulmonary infection(8 weeks)
- Total corticosteroids usage(8 weeks.)
- The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG(8 weeks.)
研究者
Wang mengzhao
Chief Director of Department of Respiratory and Critical Care Medicine
Peking Union Medical College Hospital
研究点 (5)
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