Overview

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.