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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.
• Treatments: Pirfenidone

Criteria

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.