Tests efbemalenograstim alfa to prevent low white blood cell counts during chemotherapy
Tests efbemalenograstim alfa in adults with ovarian or cervical cancer receiving chemotherapy.
Plain-language title generated from the registry record
Registry title: Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen
Key facts
- Where
- Changsha, Hangzhou, Jinan, Nanjing, Qingdao, and Taiyuan, ChinaSee the 6 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 70 with ovarian or cervical cancer who will get paclitaxel plus carboplatin or cisplatin chemotherapy and have at least one risk factor for febrile neutropenia.
- Age
- 18 to 70 years
- Sex
- Women only
- Disease stage
- First-line epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer), or first-line or recurrent/metastatic cervical cancer. Planned 3-6 cycles of chemotherapy. ECOG score below 2 and expected survival over 3 months.
- Earlier treatment
- Planned to get paclitaxel plus carboplatin or cisplatin, with or without bevacizumab. Cannot have had recombinant human granulocyte colony-stimulating factor within 6 weeks before joining.
- Biomarker or test result
- Before joining: neutrophil count (ANC) at least 2.0 × 10^9/L, hemoglobin at least 90.0 g/L, platelets at least 80 × 10^9/L, and LVEF above 50%.
Main reasons for not taking part
- Uncontrolled infection, or antibiotics given into the body within 72 hours before chemotherapy
- Pregnant or breastfeeding
- Past bone marrow or stem cell transplant
- Another cancer besides the ovarian or cervical cancer
- Known HIV or AIDS, hepatitis C, or active tuberculosis
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06251947, who can take part
Where in China
- Xiangya Hospital Central South UniversityChangsha, ChinaNot yet recruiting
- Zhejiang Cancer HospitalHangzhou, ChinaNot yet recruiting
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- Zhongda Hospital, School of Medicine, Southeast UniversityNanjing, ChinaNot yet recruiting
- Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University,Qingdao, ChinaNot yet recruiting
- Shanxi Provincial Cancer HospitalTaiyuan, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shandong University
- Trial code
- NCT06251947
- Record updated
- 7 May 2024
- Original description
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).Read full original descriptionShow less
A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial
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).
Inclusion: ≥ 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.
Exclusion: 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; 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; Known positive serum reaction for human immunodeficiency virus (HIV) or AIDS; Pregnant or lactating women; Sickle cell anemia patients.