lung cancer
Conditions
Interventions
Experiment Group:Telpegfilgrastim Injection
Control group: Two types of PEG-rhG-CSFs
Sponsors
the Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-small cell lung cancer diagnosed by pathologic histology 2. Patients aged 18-75 years, regardless of gender 3. patients who have not previously received radiotherapy or chemotherapy 4. patients who can complete simultaneous radiotherapy or at least 2 cycles of standardized first-line chemotherapy with at least one FN risk factor, and the investigator chooses the appropriate standardized radiotherapy regimen according to the specific conditions of the disease 5. ECOG scores: 0-2 points 6. Expected survival = 3 months 7. Normal function of major organs, i.e., the following criteria are met: 1) Blood tests must meet the following criteria (no transfusion of blood or blood products within 14 days, and no correction with G-CSF and other hematopoietic stimulating factors): a. HB = 75 g/L; b. ANC = 1.5 × 10^9/L; c. PLT = 80 × 10^9/L; 2) Biochemistry must meet the following criteria: a. TBIL = 1.5 × 109/L; b. ANC = 1.5 × 109/L; c. PLT = 80 × 109/L; d. PLT = 80 × 109/L; e) PLT = 80 × 109/L. a. TBIL 50 ml/min (Cockcroft-Gault formula); 3) Lung function: FEV = 1L or >50% of predicted 8. Females of childbearing potential should ensure that contraception is used for the duration of study entry 9. Subjects Voluntarily enroll in the study and sign the informed consent form, good compliance and cooperate with the follow-up visits
Exclusion criteria
Exclusion criteria: 1. patients with prior chemotherapy, radiotherapy, bone marrow transplantation, or stem cell transplantation (except induction chemotherapy as specified in the study); 2. concurrent malignancies other than primary non-small cell lung cancer; enrollment is possible for two of the following: other malignancies treated with a single surgical procedure to achieve 5 consecutive years of disease-free survival (DFS); cured carcinoma in situ of the uterine cervix, skin cancer that is not melanoma, and Superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating the basement membrane)]; 3. Received polyethylene glycolized recombinant human granulocyte-stimulating factor within 3 weeks prior to randomization, and Chinese herbal preparations with whitening effect within 1 week prior to randomization; 4. Suffer from severe cardiovascular disease: grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias ( Including QTc interval =450 ms for men and =470 ms for women; Grade III-IV cardiac insufficiency according to the standard of New York Heart Association (NYHA), or cardiac ultrasound suggesting that the left ventricular ejection fraction (LVEF) is <50%; 5. Accompanied by illnesses that may lead to splenomegaly, such as all kinds of acute and chronic infectious diseases, cirrhosis of the liver, chronic right heart failure, portal vein thrombosis, chronic Various acute and chronic infectious diseases, liver cirrhosis, chronic right heart failure, portal vein thrombosis, chronic constrictive pericarditis, Banti's syndrome; various types of leukemia, malignant lymphoma, hemophagocytic syndrome; disseminated lupus erythematosus, dermatomyositis, polyarteritis nodosa, juvenile rheumatoid arthritis; Gaucher's disease, eosinophilic granulomatosis; splenic artery aneurysm, lymphangiomatous lymphoma, dermatoid cysts, etc.; 6. Presence of active or uncontrolled serious infections (=CTC AE 2 infection); the presence of untreated Active hepatitis (Hepatitis B: HBsAg positive with HBV DNA =500 IU/mL; Hepatitis C: HCV RNA positive with abnormal liver function); co-infection with Hepatitis B and Hepatitis C; 7. Pregnant or breastfeeding female; 8. Known human immunodeficiency virus (HIV) seropositive or AIDS; 9. Active tuberculosis; or recent history of tuberculosis patient contact A history of contact with a tuberculosis patient, unless a tuberculin test is negative; or a patient receiving treatment for tuberculosis; or a suspected case of tuberculosis on chest radiograph; 10. Patients with sickle cell anemia, aplastic anemia, thalassemia, myelodysplastic syndromes, or myelofibrosis; 11. Patients with alcoholism or drug abuse that would interfere with adherence to participation in the study; 12. Known allergy to granulocyte colony-stimulating factors Known hypersensitivity to granulocyte colony-stimulating factor or excipients of the drug; 13. Use of other investigational drugs within 1 month prior to enrollment in the study or within 5 half-lives of other investigational drugs (whichever is longer); 14. Disease or condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study, where investigational drugs may impair the patient's health, or that may influence the determination of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of 3/4-degree neutropenia during the first cycle of chemotherapy;Incidence of 3/4-degree neutropenia during radiotherapy cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of 3/4-degree neutropenia by chemotherapy cycle;Incidence of neutropenic fever (FN) by cycle of chemotherapy or radiation therapy;Incidence of neutropenia resulting in decreased chemotherapy dose, delayed or interrupted chemotherapy by chemotherapy cycle or radiotherapy cycle;Incidence of infections by chemotherapy or radiotherapy cycle and throughout the treatment period;Safety; | — |
Countries
China
Contacts
Public ContactMa Hongbing
the Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed