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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT04542356
Eligibility Criteria:
Inclusion Criteria:
* 18-70 years old;
* Patients with cervical cancer who have not undergone surgery for initial treatment, the international union of gynecology and obstetrics (FIGO) stage IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology.
* The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;
* Bone marrow hematopoietic function is normal before treatment (ANC≥1.8×109/L, PLT≥100×109/L, Hb≥90g/L, WBC≥4.0×109/L);
* No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction;
* All patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment, and women of childbearing age must have a negative urine pregnancy test prior to treatment administration;
* The subjects voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion Criteria:
* Those who refuse to accept PEG-rh-G-CSF;
* Currently conducting clinical trials of other drugs;
* Uncontrolled infection before treatment, body temperature ≥ 38℃;
* Chronic diseases of the heart, kidney, liver or other important organs;
* Patients with severe uncontrolled diabetes;
* Pregnant or lactating female patients;
* Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli;
* Suspected or confirmed drug, substance or alcohol abuse;
* Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation;
* HIV-positive people;
* Patients requiring radiation therapy for the retroperitoneal or inguinal region.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04542356
Study Brief:
Protocol Section:
NCT04542356