Lung cancer, breast cancer, intestinal cancer, gynecological cancer, esophageal cancer, head and neck cancer, bone tumor, lymphoma, myeloma and other malignant tumors
Conditions
Interventions
Patients who had received a trial drug before the trial:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients with malignant tumors such as lung cancer, breast cancer, bowel cancer, gynecological tumors, esophageal cancer, head and neck cancer, bone tumors, lymphoma, myeloma and other malignant tumors confirmed by imaging and histopathology examinations from January 1, 2023 to June 1, 2024, and have been assessed by the investigator to have indications for the use of PEG-rhG-CSF; 2) prophylactic use of PEG-rhG-CSF; 3) Received at least 2 cycles of chemotherapy regimen treatment; 4) No obvious signs of hematologic disease, WBC >3.0×109/L or ANC>=1.5×109/L before the first cycle of chemotherapy; 5) Age>=18 years
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to PEG-rhG-CSF, recombinant human granulocyte-stimulating factor and other preparations expressed by E. coli; 2) Patients with severe liver, kidney, heart and lung dysfunction; 3) Patients with bone marrow invasion; 4) Patients who have received whole-body bone radiotherapy within 15 days prior to the first dose of PEG-rhG-CSF; 5) Severe infection occurred within 1 or 2 weeks prior to the first use of PEG-rhG-CSF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 3(0.5 × 109 L = anc < 1.0 × 109 L) and grade 4(anc < 0.5 × 109 L) neutrophil reduction rates per chemotherapy cycle;Number of FN-related rehospitalizations during the observation period;Whether to reduce the chemotherapy dose;Rate of delay in chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Types and severity of adverse events; | — |
Countries
China
Contacts
Public ContactLi Zhu
Shanghai General Hospital
Outcome results
None listed