Title
Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury
Phase
Phase 2Lead Sponsor
GNI GroupStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Radiation PneumonitisIntervention/Treatment
pirfenidone ...Study Participants
48The 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.
Inclusion Criteria: 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 Exclusion Criteria: 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