Efbemalenograstim Alfa for patients with ovarian or cervical cancer undergoing chemotherapy

A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial

This study is testing if Efbemalenograstim Alfa can help prevent low white blood cell counts in patients with ovarian or cervical cancer who are getting chemotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shandong University (other)
• Drugs / interventions: bevacizumab, chemotherapy
• Locations: 6 sites (Changsha, Hunan and 5 other locations)
• Trial ID: NCT06251947 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Efbemalenograstim Alfa in preventing reductions in absolute neutrophil count (ANC) in patients with ovarian or cervical cancer receiving chemotherapy. It is a single-arm, multicenter trial that aims to enroll 83 patients, including those with primary epithelial ovarian cancer and recurrent or metastatic cervical cancer. Participants will receive Efbemalenograstim Alfa injections after chemotherapy cycles to mitigate the risk of febrile neutropenia. The study focuses on patients at high risk for ANC reduction due to various factors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with first-line epithelial ovarian cancer or recurrent/metastatic cervical cancer who are at risk for febrile neutropenia.

Not a fit: Patients who are not receiving chemotherapy or those with an ECOG score of 2 or higher may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of febrile neutropenia in patients undergoing chemotherapy for ovarian or cervical cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing neutropenia during chemotherapy, indicating potential for success.

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 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.
8. Left ventricular ejection fraction (LVEF) \> 50%.
9. 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.
10. Willing to provide written informed consent and to compliant study procedure.
11. The investigator determines that the patient can tolerate treatment with Efgbemalenograstim alfa.

Exclusion Criteria:

1. Uncontrolled infection or systemic antibiotic therapy within 72 hours prior to chemotherapy.
2. Pregnant or lactating women.
3. History of bone marrow or stem cell transplantation.
4. Concurrent malignancies other than primary ovarian or cervical cancer.
5. Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment.
6. Psychiatric illness or brain metastases.
7. Clinical, electrocardiographic, or other diagnostic evidence of acute congestive heart failure, cardiomyopathy, or myocardial infarction.
8. Diseases associated with splenomegaly.
9. 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.
10. Allergy to recombinant human granulocyte colony-stimulating factor or excipients of the study drug, or allergy to rubber.
11. Known positive serum reaction for human immunodeficiency virus (HIV) or AIDS.
12. 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.
13. Sickle cell anemia patients.
14. Use of other investigational drugs within 1 month prior to enrollment.
15. Patients who abuse alcohol or drugs, affecting their compliance with the study.
16. 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.

Where this trial is running

Changsha, Hunan and 5 other locations

• Xiangya Hospital, Central South University, — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
• Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University, — Qingdao, Shandong, China (NOT_YET_RECRUITING)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Limei Wang

Conditions: Ovarian Cancer, Cervical Cancer