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).
This study is a single-arm, multicenter clinical trial. A total of 83 patients will be enrolled, including 55 patients with primary epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and 28 patients with primary or recurrent/metastatic cervical cancer in the first-line setting. 1\) Ovarian Cancer Chemotherapy regimen (Paclitaxel + Carboplatin ± Bevacizumab): Paclitaxel 175mg/m2, intravenous infusion over 3 hours, on day 1; followed by Carboplatin Area under the curve 5(AUC5), intravenous infusion over 1 hour, on day 1; Bevacizumab 7.5-15 mg/kg, on day 1, administered as intravenous infusion; repeated every 3 weeks. (2) Cervical Cancer Chemotherapy regimen (Paclitaxel + Carboplatin/Cisplatin ± Bevacizumab): Paclitaxel 175mg/m2, intravenous infusion over 3 hours, on day 1; followed by Carboplatin AUC5, intravenous infusion over 1 hour, on day 1, or Cisplatin 50-80mg/m2, intravenous infusion over 1-3 hours, on day 1; Bevacizumab 7.5-15 mg/kg, on day 1, administered as intravenous infusion; repeated every 3 weeks. Efbemalenograstim Alfa should be administered subcutaneously, 20mg per injection, within 24-48 hours after the completion of each chemotherapy cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Efbemalenograstim Alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Xiangya Hospital, Central South University,
Changsha, Hunan, China
NOT_YET_RECRUITINGZhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
Incidence of grade 3/4 neutropenia
Incidence of grade 3/4 neutropenia during the first chemotherapy cycle for participants receiving primary prophylaxis with Efgbemalenograstim alfa in the first treatment cycle
Time frame: At the first of cycle 1 (each cycle is 21 days)
The incidence rate of Grade 3/4 ANC reduction for each cycle
The incidence rate of Grade 3/4 ANC reduction in every treatment cycle
Time frame: in every treatment cycle( each cycle is 21 days)
The incidence rate of Grade ≥2 ANC reduction for each cycle
The incidence rate of Grade ≥2 ANC reduction in every treatment cycle
Time frame: in every treatment cycle( each cycle is 21 days)
The incidence rate of FN
The incidence rate of febrile neutropenia (FN) for each cycle
Time frame: in every treatment cycle( each cycle is 21 days)
Adverse Events
Including adverse events/serious adverse events and their incidence rates
Time frame: in every treatment cycle( each cycle is 21 days)
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Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University,
Qingdao, Shandong, China
NOT_YET_RECRUITINGShanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITING