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

Study Overview
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Brief Summary
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Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

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

Official Title
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A Randomized, Controlled, Multi-site Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

Conditions
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Radiation-induced Lung Injury

Intervention / Treatment
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* Drug: Pirfenidone
* Drug: basic treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirfenidone<br>pirfenidone + basic treatment | Drug: Pirfenidone<br>* pirfenidone capsule made in China<br>Drug: basic treatment<br>* glucocorticoid and expectant treatment etc.<br>|
| Other: Controll<br>with basic treatment and without pirfenidone treatment | Drug: basic treatment<br>* glucocorticoid and expectant treatment etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLco% change | Compare DLco% from basement to the end of treatment | Week 8 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The grade change of radiation-induced lung injury |  | Week 8 and 24 | 
| The score change of CT |  | Week 8 and 24 | 
| Increase of effective lung volume |  | Week 8 and 24 | 
| The grade change of Cough, Dyspnea and Fever |  | Week 8 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pirfenidone