Radiation lung injury
Conditions
Interventions
Intervention group 1:YMN-V112 (2.0×10^8 ) combined with standard hormonal therapy
Intervention group 2:YMN-V112 (4.0×10^8 ) combined with standard hormonal therapy
Intervention group 3:YMN-V112 (8.0×10^8 ) combined with standard hormonal therapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years; 2. Has received chest radiation therapy; 3. ECOG PS score of 0-1; 4. Diagnosed with radiation-induced pulmonary injury, grade 2 (according to the CTCAE v5.0 criteria, Appendix 1), and the diagnosis is less than 2 months old; 5. Normal function of major organs, meeting the following criteria: (1) Blood test results (no use of hematopoietic growth factors or blood transfusions within 7 days): Neutrophil count >=1.5×10^9/L, platelet count >=80×10^9/L, hemoglobin >=80g/L; (2) Biochemical tests: Total bilirubin =60 mL/min (Cockcroft-Gault formula); (3) Coagulation function: INR or PT= 50%; 6. The duration of radiation-induced pulmonary injury does not exceed 2 months; 7. The patient's expected survival time is more than 6 months; 8. The patient or their legally authorized representative must be able to understand the study information, voluntarily participate in the study, and sign the consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating and non-pregnant but not taking effective contraceptive measures; 2. Those with a history of chronic bronchitis, emphysema, or pulmonary heart disease; 3. Those with a history of lung resection surgery; 4. Patients with severe lung infection confirmed tumor progression according to RECIST 1.1 criteria; 5. Uncontrollable serious systemic diseases (such as central nervous system, cardiovascular system, blood system, digestive system, endocrine system, respiratory system, genitourinary system, immune system, etc.) and mental illness; 6. Serious cardiovascular and cerebrovascular events: heart failure (NYHA class III-IV), myocardial infarction, unstable angina, severe arrhythmia, cerebral infarction, cerebral hemorrhage within 6 months; 7. Abnormal liver and kidney function: AST and ALT exceed the upper limit of normal by 2.5 times, serum creatinine exceeds 1.5 mg/dl in men and 1.4 mg/dl in women; 8. Co-infection with HIV, Treponema pallidum, tuberculosis, influenza virus, adenovirus and other respiratory infections; 9. Bleeding or thrombus requiring hemostatic or anticoagulant therapy; 10. Those with leukopenia (WBC < 3 × 10^9 / L) or granulocytopenia (WBC < 1.5 × 10^9 / L or neutrophils < 0.5 × 10^9 / L) due to any cause; 11. Combined cachexia or other organ failure (requiring organ support); 12. Shock or invasive ventilation; 13. Pneumonia or pulmonary interstitial injury caused by other causes, or lung imaging shows pneumonia or pulmonary interstitial injury before the diagnosis of radiation lung injury; 14. Patients who have participated in stem cell clinical research; 15. The investigator believes that the subject has other reasons that make him or her unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory clinical dosage;Preliminary efficacy;Biomarker ; | — |
Countries
China
Contacts
Public ContactZhenyu Ding
West China Hospital, Sichuan University
Outcome results
None listed