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

Conditions

Radiation-induced Lung Injury

Keywords

pirfenidone

Brief summary

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

Detailed description

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

Pan QY, Wang YX, Tang XY, Hou Z, Dong BQ, Li QW, Chen BQ, Bai SM, Wu CF, Chen M.

2026-08-05

10.1371/journal.pmed.1004817

Pirfenidone for grade 2 and grade 3 radiation-induced lung injury: a multicentre, open-label, randomised, phase 2 trial.

Hou Z, Dong B, Yao Q, Chen H, Shao Q, Li M, Wang J, Chen K, Zhu Z, Peng F, Wei S, Hu X, Li J, Liu M, Xu B, Zheng S, Bi N, Zheng S, Xu Q, Chen B, Wu C, Li R, Chen W, Liu X, Tian Y, Li X, Guo S, Zhao L, Zhu Y, Cai L, Li Q, Li L, Zhang H, Hu C, Wang L, Li Q, Chen B, Chen M.

2025-11-06

10.1016/s1470-2045(25)00515-7

Pirfenidone for the prevention of radiation-induced lung injury in patients with locally advanced oesophageal squamous cell carcinoma: a protocol for a randomised controlled trial

Cheng Chen, Bangwei Zeng, Dan Xue, Rongxiang Cao, Siqin Liao et al. (10 authors)

BMJ Open2022-10-017 citations

10.1136/bmjopen-2021-060619

Progress in the mechanism of radiation-induced lung injury

Hangjie Ying, Min Fang, Ming Chen

Chinese Medical Journal2020-09-0313 citations

10.1097/cm9.0000000000001032

Interventions

DRUGbasic treatment

glucocorticoid and expectant treatment etc.

DRUGPirfenidone

pirfenidone capsule made in China

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. 18-75 years old (including 18 and 75 years); 2. clinically diagnosed grade 2 or 3 radiation-induced lung injury; 3. the course of radiation-induced lung injury is less than 2 months; 4. ECOG 0-2; 5. the expected survival time is more than 6 months; 6. 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 7. capable of eating solid food upon enrollment; 8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion criteria

1. have a history of chronic bronchial acute attack or severe pulmonary heart disease; 2. pneumonectomy; 3. tumor progression; 4. severe pulmonary infection; 5. creatinine clearance rate \< 30ml/min, severe renal disease or need dialysis; 6. 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; 7. patients with active peptic ulcer; 8. pregnant women and patients with mental illness; 9. participating in clinical trials of other drugs within 3 months; 10. the investigator determined that subject was not suitable.

Design outcomes

Primary

Measure	Time frame	Description
DLco% change	Week 4, 8,16, and 24	Compare DLco% from basement to the end of treatment

Secondary

Measure	Time frame
The grade change of radiation-induced lung injury	Week 4, 8,16, and 24
The score change of CT	Week 4, 8,16, and 24
Increase of effective lung volume	Week 4, 8,16, and 24
The grade change of Cough, Dyspnea and Fever	Week 4, 8,16, and 24

Countries

China

Outcome results

None listed