Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04773327
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04773327
Study Brief:
Protocol Section:
NCT04773327