Colorectal cancer
Conditions
Interventions
Experimental group:The test drug PEG-rhG-CSF injection was administered 24-48 hours after the end of oxaliplatin intravenous infusion
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, =3 neutropenia with CapeOX regimen in the previous cycle; 4. ECOG score 0-2 points; 5. Routine peripheral blood of patients: ANC >= 1.5x10^9/L, platelet count >= 90x10^9/L, Hb >= 80 g/L, and no bleeding tendency before enrollment; 6. Liver function tests for total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were all <= 2.5 times the upper limit of normal; if it was due to liver metastasis, the above indicators should be <= 5 times the upper limit of normal; 7. Renal function test: serum creatinine (Cr) does not exceed the upper limit of normal; 8. Patients voluntarily participated in the trial, signed a written informed consent, and were willing to be followed up.
Exclusion criteria
Exclusion criteria: 1. Current infection that is difficult to control, or systemic antibiotic therapy within 72 hours before chemotherapy; 2. Any abnormal myeloid hyperplasia and other hematopoietic dysfunction; 3. Patients who have received bone marrow or hematopoietic stem cell transplantation within the past 3 months; 4. Patients with other malignant tumors that have not been cured in the past, or patients with brain metastases; 5. Those who are allergic to this product or other biological products derived from genetically engineered Escherichia coli; 6. Suffering from mental or nervous system disorders, lack of insight or inability to cooperate; 7. Patients with expected short survival and refractory to chemotherapy; 8. Pregnant and lactating patients; 9. Those who have used granulocyte colony-stimulating factor prophylactically in the past, or have not been completely metabolized by other test drugs of the same type (6 half-lives or more after medication are considered to be completely metabolized), or are undergoing clinical trials of other drugs; 10. Patients with body weight < 45kg; 11. Investigators deemed unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of 2-4 grade neutropenia during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of febrile neutropenia (FN);Proportion of dose adjustment due to neutropenia;Proportion of delayed chemotherapy due to neutropenia;Adverse event; | — |
Countries
China
Contacts
Public ContactQu Xiujuan
The First Affiliated Hospital of China Medical University
Outcome results
None listed