Clinical Study of Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of Checkpoint Inhibitor-related Pneumonitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Degradation time of CIP
研究概览
简要总结
Checkpoint inhibitor-related pneumonitis (CIP）is a common fatal immune-related adverse event of PD-1/PD-L1 inhibitors. Some CIP patients have poor effect on hormone therapy, and the remission time of CIP varies greatly. Antifibrotic drugs may be effective in patients with CIP.
详细描述
Pirfenidone can inhibit the occurrence and development of pulmonary fibrosis, reduce pulmonary exudation by inhibiting VEGF and promote pulmonary recovery. In our study, subjects with checkpoint inhibitor-related pneumonitis receive pirfenidone plus methylprednisolone or methylprednisolone.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female who is 18 to 75 years old.
- •Malignant tumors proved by pathology.
- •The subject has received at least one course of immune checkpoint inhibitor treatment.
- •The subject developed grade 3-4 CIP.
- •Take proper contraceptive measures.
- •Appropriate organ system function.
- •Subjects voluntarily participate in this study and sign the informed consent.
排除标准
- •Previous treatment with pirfenidone.
- •Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis greater than 50ml per day); Or significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or macrovasculitis.
- •Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism.
- •Abdominal surgery was performed 4 weeks before enrollment, or there was a history of hollow organ perforation.
- •Use nintedanib, cyclophosphamide or cyclosporin within 56 days before enrollment.
- •Suffering from active pulmonary tuberculosis.
- •Patients with mental illness and poor compliance.
- •Sperm / egg donors within 6 months.
- •Lactating women.
- •Persons allergic to pirfenidone.
- •In the investigator's judgment, there are other factors that may have led to the termination of the study.
研究组 & 干预措施
Experimental group
Grade 3-4 checkpoint inhibitor-related pneumonitis
干预措施: Pirfenidone, methylprednisolone (Drug)
Control group
Grade 3-4 checkpoint inhibitor-related pneumonitis
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Degradation time of CIP
时间窗: Approximately 3 months
According to CTCAE 4.0 and imaging grade of CIP, the time of reduction by one grade was evaluated.
Proportion of degradation within three months
时间窗: Approximately 3 months
The number of enrollments reduced by grade 1 in 3 months divided by the total number of enrollments.
次要结局
- Safety(Adverse Events)(From the day the patient signs informed consent form until 30 days after the last medication)
- MMRC score(From the day the patient received treatment until 30 days after the last medication)
- Total amount of hormone(From the day the patient signs informed consent to the last medication，assessed up to 24 months)
研究者
Zhou Chengzhi
Professor
Guangzhou Institute of Respiratory Disease