radiation-induced lung injury
Conditions
Interventions
Experimental group:Pirfenidone capsules (100 mg/capsule) + basic treatment plan
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including 18 and 75 years old); 2. Clinically confirmed grade 2-3 radiation lung injury; 3. The course of radiation lung injury is less than 2 months; 4. General condition assessment, ECOG 0-2; 5. Those with an expected survival period of more than 6 months; 6. The function level of major organs meets the following standards: (1) Blood routine examination standards must meet: ANC >= 3.0 x 10^9/L, PLT >= 100 x 10^9/L, Hb >= 90 g/L; (2) Biochemical examination must meet the following standards: TBIL, BUN and Cr <= 1.5 x ULN, ALT, AST <= 2.0 x ULN; 7. Those who can eat solid food when entering the group; 8. The subjects voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with a history of acute attack of chronic bronchitis or severe pulmonary heart disease in the past; 2. Pneumonectomy patients; 3. Tumor progression; 4. Severe lung infection; 5. Creatinine clearance rate <30ml/min and severe kidney disease or need dialysis; 6. Combined with other serious diseases: such as myocardial infarction, uncontrollable diabetes, etc. within 6 months, who are considered unsuitable to participate in the experiment; 7. Patients with active peptic ulcer; 8. Pregnant women and patients with mental illness; 9. Participants in clinical trials of other drugs within 3 months; 10. It is judged by the researcher that it is not suitable for the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DLco% after treatment compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in radiation lung injury classification after treatment compared to baseline;Changes in CT scores after treatment compared to baseline;Changes in FVC and FEV1 after treatment compared with baseline;Changes in cough, shortness of breath, and grade of fever after treatment compared to baseline;24-week survival rate without acute exacerbation of pulmonary condition; | — |
Countries
China
Contacts
Public ContactMing Chen
Sun Yat-sen University Cancer Center
Outcome results
None listed