A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

The study is a randomized, controlled, multi-site clinical trial.

Inclusion criteria

• 18-75 years old (including 18 and 75 years);
• clinically diagnosed grade 2 or 3 radiation-induced lung injury;
• the course of radiation-induced lung injury is less than 2 months;
• ECOG 0-2;
• the expected survival time is more than 6 months;
• the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
• capable of eating solid food upon enrollment;
• subjects will voluntarily participate in this study and sign the informed consent.

Exclusion criteria

• have a history of chronic bronchial acute attack or severe pulmonary heart disease;
• pneumonectomy;
• tumor progression;
• severe pulmonary infection;
• creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;
• concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
• patients with active peptic ulcer;
• pregnant women and patients with mental illness;
• participating in clinical trials of other drugs within 3 months;
• the investigator determined that subject was not suitable.