Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShandong University
About this 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).
Eligibility criteria
Qualifiers
≥ 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.
Disqualifiers
Uncontrolled infection or systemic antibiotic therapy within 72 hours prior to chemotherapy.
Pregnant or lactating women.
History of bone marrow or stem cell transplantation.
Concurrent malignancies other than primary ovarian or cervical cancer.
Trial design
Treatments tested in this trial
- Efbemalenograstim Alfa
Treatment groups
83 Participants
are divided into 1 treatment groupSponsors and collaborators
Shandong University
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
Source ClinicalTrials.gov