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

Phase 2

Completed

• Conditions: Radiation-induced Lung Injury
• Interventions: Drug: Pirfenidone; Drug: basic treatment

• Registration Number: NCT03902509
• Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

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.

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Study Start: 2019-05-24
• Status Verified: 2023-12
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirfenidone	Pirfenidone	pirfenidone + basic treatment
Pirfenidone	basic treatment	pirfenidone + basic treatment
Controll	basic treatment	with basic treatment and without pirfenidone treatment

Primary Outcome Measures

Name	Time	Method
DLco% change	Week 4, 8,16, and 24	Compare DLco% from basement to the end of treatment

Secondary Outcome Measures

Name	Time	Method
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
The grade change of radiation-induced lung injury	Week 4, 8,16, and 24

Trial Locations

Locations (2)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China