This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy. Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment. The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy. The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
No. 270, Dongan Road, Xuhui District, Shanghai, China
Shanghai, Shanghai Municipality, China
Incidence of third/fourth level neutropenia
Incidence of third/fourth level neutropenia during three cycles chemotherapy
Time frame: three months
Incidence of febrile neutropenia
Incidence of febrile neutropenia during every cycle chemotherapy
Time frame: three months
The duration time of third/fourth level neutropenia
The duration time of third/fourth level neutropenia during three cycles chemotherapy
Time frame: three months
Incidence of infection
Incidence of third/fourth level neutropenia during three cycles chemotherapy
Time frame: three months
delay time of chemotherapy
The delay time of the next cycle of chemotherapy due to FN or infection
Time frame: three months
RDI of chemotherapy
Relative dose intensity of the second and third chemotherapy
Time frame: three months
Adverse events
Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: three months
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