Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies

Conditions
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Gynecologic Malignant Tumor

Intervention / Treatment
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* Other: Mecapegfilgrastim Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-70 Weight ≥45 kg ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 Expected survival time of > 3 months Main organ functions meet the following criteria: Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L; APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s; ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN; BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min; without obvious cardiac dysfunction Provided consent for participation Exclusion Criteria: With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy Pregnant or lactating women Received bone marrow or hematopoietic stem cell transplantation within the past 3 months Concurrent chemoradiotherapy Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc Presence of risk of thrombus or high risk of clotting Presence of psychosis, neurological disease or brain metastases from tumors Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin Received clinical trials within 1 month prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF prevention<br>Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle, | Other: Mecapegfilgrastim Injection<br>* 24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle<br>* Other names: PEG- rhg - csf;|
| No Intervention: non-prevention<br>Only close monitoring after chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of third/fourth level neutropenia | Incidence of third/fourth level neutropenia during three cycles chemotherapy | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia | Incidence of febrile neutropenia during every cycle chemotherapy | three months | 
| The duration time of third/fourth level neutropenia | The duration time of third/fourth level neutropenia during three cycles chemotherapy | three months | 
| Incidence of infection | Incidence of third/fourth level neutropenia during three cycles chemotherapy | three months | 
| delay time of chemotherapy | The delay time of the next cycle of chemotherapy due to FN or infection | three months | 
| RDI of chemotherapy | Relative dose intensity of the second and third chemotherapy | 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 | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenia