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
This trial does not accept healthy volunteersQualifiers
≥ 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
Design model
Single group
Treatments tested in this trial
Efbemalenograstim Alfa
DrugEfbemalenograstim 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.
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
Adverse Events
Including adverse events/serious adverse events and their incidence rates
Time frame
in every treatment cycle( each cycle is 21 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong University
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
Source ClinicalTrials.gov