Lung cancer, radiation pneumonitis
Conditions
Interventions
Concurrent control group:NO
Test group:Nintedanib prevents radiation pneumonitis
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed unresectable lung cancer requiring definitive radiotherapy with concurrent or sequential chemotherapy. 2. No restriction on the number of induction immunotherapy or chemotherapy cycles prior to definitive radiotherapy, and no restriction on consolidation immunotherapy after definitive treatment, provided that vital organ functions are preserved. 3. Age >=18 years. 4. ECOG performance status of 0–1. 5. No significant abnormalities in routine laboratory tests (hematology, liver/kidney function, coagulation, etc.): Hematologic criteria (no blood transfusion or blood products within 14 days): a. ANC >=1.5×10^9/L; b. PLT >=80×10^9/L ; Biochemical criteria: a. TBIL 45 mL/min (Cockcroft-Gault formula) 6. Patients with reproductive potential must use medically approved contraceptive measures during the study and for 1 month after treatment completion. 7. Voluntarily participate in the study, sign informed consent, and demonstrate good compliance.
Exclusion criteria
Exclusion criteria: 1. History of thoracic radiotherapy. 2. Interstitial lung disease, non-infectious pneumonitis, or concomitant severe respiratory disorders (e.g., chronic obstructive pulmonary disease [COPD], active tuberculosis). 3. Psychiatric disorders, hematological disorders, autoimmune diseases, or severe primary diseases affecting the heart, brain, liver, or kidneys. 4. Thrombotic or embolic disorders, coagulopathy, or hemorrhagic tendency. 5. Pregnancy, lactation, or positive baseline pregnancy test in women of childbearing potential. 6. Other factors deemed by the investigator to potentially necessitate study termination, including: Severe comorbidities (e.g., psychiatric illnesses) requiring concomitant treatment; Significant laboratory abnormalities; Social or familial circumstances compromising patient safety or data/sample collection.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life score;Changes in pulmonary function one month after radiotherapy compared with the baseline (including FVC, FEV1, DLCO);Pneumonia classification one month after radiotherapy; | — |
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade >=2 RP 3 months after radiotherapy; | — |
Countries
China
Contacts
Public ContactXudong Hu
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed