NCT02296281Unknown2 期
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
Beijing Continent Pharmaceutical Co, Ltd.0 个研究点目标入组 48 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 主要终点
- Changes in radiation-induced lung injury classification
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of pirfenidone capsules to treat grade 2 or above radiation-induced lung injury patients.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old (include 18 and 70 years), male or female
- •The pathological diagnosis of lung cancer, with non-small cell lung cancer (NSCLC) staging IIIA or IIIB, and small cell lung cancer (SCLC) in council deadline
- •General condition assessment, ECOG score of 0-1
- •Enough heart, liver and kidney function, such as AST, ALT, LDH≤2 times ULN such as plasma total bilirubin, creatinine ≤1.5 times ULN; hematopoietic function enough, such as neutrophils ≥4.0 x109 / L, platelets ≥100 x109 / L
- •The expected survival at 6 months or more
- •Subject is able to eat solid food
- •The initial radical thoracic radiotherapy treatment
- •The clinical diagnosis of radiation-induced lung injury in Grade 2 or above
- •The duration of radiation-induced lung injury in less than 1 month
- •Signed informed consent
排除标准
- •Radiation-induced lung injury has entered the chronic phase
- •A history of chronic bronchitis, emphysema, or a history of cor pulmonale
- •Lung resection surgery
- •Cancer progression
- •Pulmonary infection
- •Associated with other serious diseases: such as occurred within 6 months of myocardial infarction, uncontrolled diabetes etc.
- •With active peptic ulcer
- •Pregnant women and patients with mental disease
- •Those who participate in clinical trials of other drugs within 3 months
- •Investigator judge does not apply to participate in the trial
研究组 & 干预措施
treatment group
Experimental
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Changes in radiation-induced lung injury classification
时间窗: 36 Weeks
次要结局
未报告次要终点
研究者
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