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OncoMatch/Clinical Trials/NCT06251947

Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

Is NCT06251947 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Efbemalenograstim Alfa for ovarian cancer.

Phase 2RecruitingShandong UniversityNCT06251947Data as of May 2026

Treatment: Efbemalenograstim AlfaThe 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).

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Cervical Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: bone marrow or stem cell transplantation

History of bone marrow or stem cell transplantation

Cannot have received: recombinant human granulocyte colony-stimulating factor

Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment

Cannot have received: other investigational drugs

Use of other investigational drugs within 1 month prior to enrollment

Lab requirements

Blood counts

ANC ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 90.0 g/L, platelet (PLT) ≥ 80 × 10^9/L

Kidney function

creatinine clearance rate < 50 mL•min-1 (renal dysfunction is a risk factor for FN)

Liver function

bilirubin > 2.0 mg•dL-1 (hepatic dysfunction is a risk factor for FN); exclusion if acute infection, chronic active hepatitis B within 1 year (unless known negative for hepatitis B virus antigen prior to enrollment), or hepatitis C

Cardiac function

Left ventricular ejection fraction (LVEF) > 50%; exclusion if acute congestive heart failure, cardiomyopathy, or myocardial infarction

Before enrollment, neutrophil count (ANC) ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 90.0 g/L, and platelet (PLT) ≥ 80 × 10^9/L. LVEF > 50%. Hepatic dysfunction (bilirubin > 2.0 mg•dL-1) and renal dysfunction (creatinine clearance rate < 50 mL•min-1) are risk factors for FN. Exclusion if acute congestive heart failure, cardiomyopathy, or myocardial infarction.

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