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

Xiaohua Wu MD

Status

Unknown

Conditions

Gynecologic Malignant Tumor

Treatments

Other: Mecapegfilgrastim Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04773327

MA-GynC-II-001

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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:
1. Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
2. APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
3. ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
4. BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
5. 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