Non-small cell lung cancer
Conditions
Interventions
Experimental group :Subcutaneous injection of PEG-rhG-CSF 48 hours after the chemotherapy
Control group:Subcutaneous injection of rhG-CSF when WBC<2.0×10^9/L or ANC=1.0×10^9/L during the chemotherapy
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 years old male and female; (2) Non-small cell lung cancer patients diagnosed by histopathology or cytology; (3) Patients requiring multi-cycle adjuvant chemotherapy; (4) Plan to accept a platinum-containing two-drug program; (5) KPS score = 70 points; (6) The estimated survival period is more than 3 months; (7) No obvious signs of hematological disease, Hb=7.5g/dL,WBC=3.0×10^9/L,ANC = 1.5×10^9/L, PLT = 80×10^9/L. And no bleeding tendency; (8) No obvious abnormalities were observed in the electrocardiogram examination; (9) Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of the normal value. If due to liver metastasis, the above indicators should be within 5 times the normal upper limit. If LDH is elevated due to non-tumor causes, LDH should be =2.5The normal upper limit; if the increase in LDH is caused by a tumor, it can be enrolled; (10) Renal function test BUN, Cr, UA within 1.5 times the upper limit of normal; (11) Subjects (or their legal representatives/guardians) must sign an informed consent indicating that they understand the study, understand the necessary procedures for research.
Exclusion criteria
Exclusion criteria: (1) There are currently uncontrollable infections, body temperature = 38.0 degree C; (2) Female patients during pregnancy or lactation; women of childbearing age who refuse to receive contraception; (3) At the same time use other trial drugs or trials; (4) Those who are allergic to this product or other genetically engineered E. coli-derived biological products; (5) Have received hematopoietic stem cell transplantation or organ transplantation; (6) Severe mental or neurological disorders affecting informed consent and/or adverse reaction presentations or observations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of degree III/IV ANC reduction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and duration of degree III/IV ANC reduction;Incidence and duration of FN; | — |
Countries
China
Contacts
Public ContactJunfeng Liu
The Fourth Hospital of Hebei Medical University
Outcome results
None listed