Neutropenia
Conditions
Interventions
single arm:Thiopeifegestin
Sponsors
Huainan First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-79 years old; 2. Patients with unlimited gender; 3. Patients with NSCLC confirmed by histopathology or cytology; 4. patients with WHO (WHO) / eastern United States tumor cooperation group (ECOG) physical status score of 0~2 were enrolled; 5. Patients who are expected to complete 4 cycles of chemotherapy; 6. Patients with normal bone marrow function who have not received chemotherapy in the past 3 months or radiotherapy in the past 6 months; 7. Patients with normal hematopoietic function and no bleeding tendency (INR = 90 g / L; WBC >= 4.0 * 10 ^ 9 / L; ANC >= 2.0 * 10 ^ 9/L, PLT >= 100 * 10^9/ L; (2) Liver function and biochemical examination: ALT and AST <= 1.5 * ULN; total bilirubin <= 1.5 * ULN; serum creatinine (CR) <= 1.5 * ULN; 9. The subjects volunteered to join the study, signed the informed consent, had good compliance and cooperated with the follow-up; 10. The researchers believe that treatment can benefit.
Exclusion criteria
Exclusion criteria: 1. Patients who have been proved to be allergic to the test drug and / or its auxiliary materials; 2. Patients with other malignant tumors in the past; 3. Patients with hematopathy, leukemia and other related diseases that interfere with the research results; 4. Patients who have received hematopoietic stem cell transplantation or bone marrow transplantation; 5. Patients with uncontrollable infection after chemotherapy; 6. Patients with brain metastasis or meningeal metastasis with clinical symptoms. Patients with brain metastases after treatment need to meet the following conditions before entering the group: there is no progress confirmed by MRI at least 4 weeks after the end of treatment, the treatment is completed at least 28 days before the first dose of study drug, and systemic corticosteroids (> 10mg / day prednisone or equivalent dose) are not needed at least 14 days before the first dose of study drug; 7. Diagnosis of patients with bone marrow metastasis; 8. Patients with interstitial pneumonia (ILD), drug-induced pneumonia, radiation pneumonia requiring steroid treatment, or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 9. Patients with clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA grade 2 and above heart failure; (2) Unstable angina; (3) Myocardial infarction within 24 weeks; (4) Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention; 10. Active tuberculosis or subjects with a history of active tuberculosis infection <= 48 weeks before screening, whether or not they are treated; 11. Patients with serious and uncontrollable diabetes; 12. Pregnant or lactating women; 13. According to the judgment of the researcher, the patients who are not suitable to be included in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of FN;Recovery time of neutropenia;Adverse events; | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3-4 ANC reduction; | — |
Countries
China
Contacts
Public ContactYanshun Zhang
Huainan First People's Hospital
Outcome results
None listed