Small cell lung cancer
Conditions
Interventions
Test group:The experimental group was given a subcutaneous injection of Mecapegfilgrastim 6mg 24-48h after each cycle of chemotherapy
Control group:The first cycle was observed only, with dose-restricted neutropenic events or FN occurring, and the second cycle was treated with secondary prophylaxis of Mecapegfilgrastim
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University / The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Small cell lung cancer diagnosed hiopathologically without chemotherapy can complete at least 2 cycles of the standard first-line chemotherapy regimen as planned, and contain at least one FN risk factor, according to the specific condition, the standard chemotherapy regimen can be selected, and immunotherapy can be combined if the condition requires it; 2.Aged 18 to 75 years, regardless of gender; 3.Weight >= 45 kg; 4.ECOG score: 0-2; 5.The main organs of the patient function normally without serious complications; Main organs function normally and meet the following criteria: (1)No diseases related to bone marrow hematopoietic dysfunction and no bleeding tendency (INR= 90g/L; 2)WBC >=3.5x10^9/ L; 3)ANC >=2.0x10^9/L;4) Platelet Count (PLT) >=100x10^9/L; (3)Biochemical examination shall meet the following criteria:1)ALT <= 2.5xULN; 2)AST <=2.5xULN; 3)TBIL <=1.5xULN; If caused by liver metastasis, the above indexes should be <=5xULN D serum creatinine <=1.5xULN; (4)No obvious heart and lung dysfunction; 6.Volunteer to participate in the clinical trial, understand the study procedures and be able to sign the informed consent in person.
Exclusion criteria
Exclusion criteria: 1.Has an infection that is difficult to control, or received systematic antibiotic treatment within 72 hours before chemotherapy; 2.Previous cases of other malignant tumors have not been cured; 3.Previous history of bone marrow and/or stem cell transplantation; Have other hematologic diseases that affect the hematopoietic function of bone marrow; 4.Concomitant diseases that, as judged by the investigator, seriously endanger the patient's safety or affect the completion of the study; 5.Previous history of radiotherapy and chemotherapy for other malignant tumors; 6.People who are allergic to the study drug or other G-CSF products or biological agents expressed by E. coli; 7.Suffer from mental or nervous system diseases and cannot cooperate; 8.Pregnant or lactating female patients;Potential fertile subjects refuse to accept contraceptive measures; 9.Subjects who participated in other clinical studies during treatment, or who took the first dose less than 4 weeks (or 5 half-lives of the investigational drug) from the bundle junction (last dose) of the previous clinical study; 10.The researcher thinks it is not suitable for participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of 3/4 degree neutropenia in both groups during the first cycle of chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of fibronectin in two groups during the first cycle of chemotherapy;The incidence of 3/4 degree neutropenia in two groups during the second cycle of chemotherapy;The incidence of fibronectin in two groups during the second cycle of chemotherapy;The incidence of 3/4 degree neutropenia in both groups after two cycles of chemotherapy;The incidence of fibronectin in both groups after two cycles of chemotherapy;Security accident; | — |
Countries
China
Contacts
Public ContactYang Shuanying
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed