Status:
UNKNOWN
Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies
Lead Sponsor:
Xiaohua Wu MD
Conditions:
Gynecologic Malignant Tumor
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04773327
Start Date
May 1 2021
End Date
August 1 2022
Last Update
February 26 2021
Active Locations (1)
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1
No. 270, Dongan Road, Xuhui District, Shanghai, China
Shanghai, Shanghai Municipality, China