Chemotherapy-induced neutropenia
Conditions
Interventions
experimental group:Thiopifegestin injection (PEG-rhG-CSF)
Sponsors
Quanzhou First Hospital
Eligibility
Sex/Gender
All
Age
17 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patients with non myeloid malignant tumor confirmed by histopathology developed neutropenia after neoadjuvant, adjuvant and palliative chemotherapy. The chemotherapy cycle was 14 days or 21 days. 2. Patients with ECoG PS 0-2; 3. Patients aged 18-70 years old, male or female; 4. Patients whose expected survival time is more than or equal to 12 weeks; 5. Patients who are expected to complete at least one cycle of chemotherapy as planned; 6. Blood routine examination should meet the following requirements: (1) ANC >= 1.5 x 10^9/L; (2) Hb >= 90g/L; (3) PLT >= 100 x 10^9/L; 7. Liver function and biochemical tests should meet the following standards: (1) ALT and AST <= 2.5 x ULN; (2) TBIL <= 1.5 x ULN; (3) Serum creatinine <= 1.5 x ULN; 8. Subjects without obvious cardiac and pulmonary dysfunction; 9. The subjects judged by the researcher to be able to comply with the trial protocol; 10. The subjects who voluntarily participate in this clinical trial understand the research procedure and can sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of bone marrow transplantation and / or stem cell transplantation; 2. Patients with acute or active infection received systemic anti infection therapy within one week; 3. Patients with other hematological diseases affecting the hematopoietic function of bone marrow; 4. According to the judgment of the researchers, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 5. Pregnant or lactating women; 6. Patients who participated in clinical trials of other drugs within 4 weeks before enrollment; 7. Patients who had received peg rhG CSF, rhG CSF and the drugs in this study within 2 weeks before enrollment; 8. Patients allergic to research drugs, rhG CSF or other biological products; 9. Patients who had received radiotherapy within 4 weeks before enrollment; 10. Patients with drug addiction or history of drug abuse; 11. It is not suitable to use other conditions specified in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ANC reduction >=3 degrees; | — |
Countries
China
Contacts
Public ContactLi Xiaofeng
Quanzhou First Hospital
Outcome results
None listed