Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen
Trial Parameters
Brief Summary
The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in Ovarian and Cervical cancer patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN).
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years old and ≤ 70 years old. 2. First-line epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and first-line treatment or recurrent/metastatic cervical cancer. 3. Planned to receive 3-6 cycles of paclitaxel + carboplatin/cisplatin ± bevacizumab therapy. 4. Eastern Cooperative Oncology Group (ECOG) score \< 2. 5. Expected survival time \> 3 months. 6. Before enrollment, neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 90.0 g/L, and platelet (PLT) ≥ 80 × 10\^9/L. 7. Associated with ≥ 1 self-factors increasing the risk of febrile neutropenia (FN): ① age \> 65 years, receiving full-dose intensity chemotherapy; ② history of previous chemotherapy or radiotherapy; ③ persistent neutropenia; ④ tumor involvement of the bone marrow; ⑤ recent surgery and/or open wounds; ⑥ hepatic dysfunction (bilirubin \> 2.0 mg•dL-1); ⑦ renal dysfunction (creatinine clearance rate \< 50 mL•min-1); ⑧ history of previous FN occurrence; ⑨ c