Lung cancer
Conditions
Interventions
Experimental group:Nintedanib in combination with glucocorticoids
Control group:Glucocorticoid administration
Sponsors
The Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age = 18 years, gender not limited; 2.ECOG score of 0~1; 3.Expected survival time =24 weeks; 4.Pathologically or cytologically confirmed malignant neoplasm of the lung, with clinical grade 2 or 3 radiation pneumonitis (CTCAE 5.0 criteria) occurring after the initiation of chest radiation therapy; 5.Any other acute toxic reactions caused by radiotherapy have been reduced to grade 1 or below (excluding asthenia and alopecia); 6.Patients with potential to conceive must use appropriate contraception during the study treatment period and for 1 month after the end of study treatment; 7.The subjects were volunteers who participated in the study and signed the informed consent form, and had good compliance.
Exclusion criteria
Exclusion criteria: 1.Allergic to any ingredient of the test drug; 2.Combined with other severe pulmonary diseases (such as active pulmonary tuberculosis, moderate to severe chronic obstructive pulmonary disease, uncontrolled, moderate to severe pulmonary artery hypertension, etc.), and other reasons caused interstitial lung disease (such as idiopathic interstitial pneumonia, connect tissue disease-related interstitial lung disease, allergic pneumonitis, drug-induced lung injury, pneumoconiosis, and interstitial lung disease with clear progression, etc.). 3.Subjects with swallowing difficulties or with clinically significant gastrointestinal function disorders that may interfere with the uptake, transport, or absorption of the study drug, including but not limited to malabsorption syndromes, poorly controlled nausea or vomiting, history of large area of gastrectomy or small bowel resection, uncontrolled diarrhea, gastritis with atrophy (in subjects younger than 60 years of age at diagnosis), gastric disorders requiring long-term treatment with proton pump inhibitors (PIs), symptomatic inflammatory bowel disease, partial or complete intestinal obstruction, etc. 4.Use any of the following medications used to treat interstitial lung disease (ILD) concurrently: azathioprine, cyclophosphamide, cyporine, mycophenolate mofetil (MMF), tacrolimus, oral corticosteroids, pirfenidone; 5.Cardiovascular disease, meets any of the following: Severe hypertension (=160/100 mmHg) that is not well controlled despite treatment 6 months; Myocardial infarction within 6 months; Unstable angina within 6 months; 6.a. Bleeding risk, met any of the following: A known inherited bleeding tendency. Patient requiring any of the following therapies: fibrinotic therapy; full-dose therapeutic anticoagulation (e.g., vitamin K antagonist, direct thrombin inhibitor, heparin, danapoid); high-dose antiplatelet therapy. [Note: Prophylactic low-dose heparin or heparin flush (e.g., enaparin 4000 IU SC QD) to maintain patency of a placed venous device and prophylactic use of antiplatelet therapy (eg., acetylsalicylic acid =325 mg/day, or clopidogrel 75 mg/day, or equivalent dose of antiplatelet therapy) are not excluded]. History of bleeding CNS event within 12 months; hemoptysis, hematuria, active gastrointest bleeding or ulcer, major trauma or surgery within 3 months; b. Thrombotic risk: history of thrombotic event within 12 months (including and transient ischemic attack); c. Coagulation parameters: International normalized ratio (INR) >2, prothrombin time (PT) and activated partial thboplastin time (aPTT) prolonged >1.5x ULN; 7.Aspartate aminotransferase (AST) >1.5 ULN; Alanine aminotransferase (ALT) >15 ULN; Total bilirubin (TBIL) >1.5 ULN; 8.HIV antibody positive; Hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) and hepatitis B virus deoxyribonucleic acid (HBV DNA) =2×103 IU/ml, or hepatitis C virus (HC) antibody positive; 9.There are other factors that may also lead to the termination of this study, such as the need for combined treatment of other serious diseases (including mental illness) severe laboratory test abnormalities, and family or social factors that may affect the safety of the subjects or the collection of data and samples, at the investigator's judgment. 10.Baseline pregnancy test positive in pregnant and lactating women or women of childbearing potential; 11.The investigator determines the patient is unfit to enter this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in FVC at week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Week 52 absolute change in FVC from baseline;Week 24 and 52 change in % predicted DLCO;Week 24 and 52 change in SGRQ score; | — |
Countries
China
Contacts
Public ContactWang Linlin
The Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed