Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

Korábbi kezelés

• Uncontrolled infection or systemic antibiotic therapy within 72 hours prior to chemotherapy.
• Concurrent malignancies other than primary ovarian or cervical cancer.
• Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment.
• Diagnosis of acute infection, chronic active hepatitis B within 1 year (unless known negative for hepatitis B virus antigen prior to enrollment), or hepatitis C.
• Active tuberculosis or recent history of contact with a tuberculosis patient unless negative on tuberculin skin test, or receiving treatment for tuberculosis, or suspected case on chest X-ray examination.
• Use of other investigational drugs within 1 month prior to enrollment.
• Patients who abuse alcohol or drugs, affecting their compliance with the study.

Más betegség

• History of bone marrow or stem cell transplantation.
• Psychiatric illness or brain metastases.
• Clinical, electrocardiographic, or other diagnostic evidence of acute congestive heart failure, cardiomyopathy, or myocardial infarction.
• Diseases associated with splenomegaly.
• Allergy to recombinant human granulocyte colony-stimulating factor or excipients of the study drug, or allergy to rubber.
• The investigator believes that the patient has a disease or symptom that makes them unsuitable for participation in this study, or that the study drug may harm the patient's health or affect the assessment of adverse events.

Laborértékek

• Known positive serum reaction for human immunodeficiency virus (HIV) or AIDS.

Egyéb

• Pregnant or lactating women.
• Sickle cell anemia patients.

• ≥ 18 years old and ≤ 70 years old.
• First-line epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and first-line treatment or recurrent/metastatic cervical cancer.
• Planned to receive 3-6 cycles of paclitaxel + carboplatin/cisplatin ± bevacizumab therapy.
• Eastern Cooperative Oncology Group (ECOG) score < 2.
• Expected survival time > 3 months.
• Before enrollment, neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 90.0 g/L, and platelet (PLT) ≥ 80 × 10\^9/L.
• 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 concomitant malignant hematological or lymphatic system diseases; ⑩ chronic immunosuppression; ⑪ poor nutritional/physical status. Individualized judgment and decision-making based on the patient's specific condition are required in clinical practice.
• Left ventricular ejection fraction (LVEF) > 50%.
• Women who are not capable of reproduction, i.e., postmenopausal for at least 1 year or have undergone sterilization procedures (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Fertile patients agree to use appropriate contraceptive measures within 1 month before the start of the trial and up to 30 days after the end of the study, such as condoms, spermicidal condoms, foam, gel, diaphragm, intrauterine device (IUD), contraceptive pills (oral or injectable), etc.
• Willing to provide written informed consent and to compliant study procedure.
• The investigator determines that the patient can tolerate treatment with Efgbemalenograstim alfa.