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:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT03858166
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 years or older
2. Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
3. Grade 3/4 neutropenia appeared in previous chemotherapy
4. accept at least 3 cycles of adjuvant chemotherapy
5. expected survival time ≥ 8 months; KPS\>70
6. Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L
7. No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction
8. Liver function: ALT, TBIL, AST \<= 2.5 ULN
9. Renal function: Cr, BUN \<= 1.5 ULN
10. All patients must agree to take effective contraceptive measures during the study and within 6 months after discontinuing the treatment. Females of childbearing age must be negative in urinary pregnancy test before the treatment.
11. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.
Exclusion Criteria:
1. Uncontrolled infection, temperature≥38℃
2. patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
3. undergoing any other clinical trial in 4 weeks before recruitment
4. undergoing radiotherapy in 4 weeks before recruitment
5. Patients with other malignant tumors who have not been cured or have brain metastasis
6. Liver function: ALT, TBIL, AST \> 2.5 ULN; If due to liver metastasis, ALT, TBIL, AST \> 5 ULN; Renal function: Cr\>1.5; Obvious abnormalities in electrocardiogram
7. Severe heart, kidney, liver and other important organs chronic diseases
8. severe and uncontrolled diabetes
9. Pregnancy or lactation in women or women of childbearing age refused to accept contraception
10. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
11. Suspected or confirmed drug use, drug abuse, alcoholics
12. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
13. HIV positive
14. Syphilis infection
15. The investigator believes that the patient's condition is not suitable for this clinical study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03858166
Study Brief:
Protocol Section:
NCT03858166