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:
NCT06426056
Eligibility Criteria:
Inclusion Criteria:
* (1) Stage IB3 to IVA disease based on the 2018 International Federation of Gynecology and Obstetrics (FIGO) system;
* (2) Eastern Cooperative Oncology Group at 2 or less;
* (3) Life expectancy of greater than 3 months;
* (4) Left ventricular ejection fraction at ≥55%;
* (5) Neutrophil count at ≥1500/mm\^3, platelet count at ≥100,000/mm\^3 or hemoglobin at ≥9.0 g/dL;
* (6) Serum creatinine at \<1.5 times the upper limit of the normal reference range;
* (7) Alanine transaminase or aspartate aminotransferase at \>2.5 times the upper limit of the normal reference range;
* (8) Non pregnant or lactating women;
* (9) Women of childbearing age willing to adopt reliable contraceptive measures;
* (10) Sign informed consent form.
Exclusion Criteria:
* (1) Individuals who have previously received chemotherapy with albumin bound paclitaxel;
* (2) Individuals who have previously received abdominal or pelvic radiation therapy;
* (3) Individuals who have received neoadjuvant chemotherapy or targeted, immunotherapy, and other anti-tumor treatments prior to concurrent chemoradiotherapy and chemotherapy;
* (4) Individuals with central nervous system diseases or brain metastases；
* (5) Other malignant tumors other than cervical cancer have appeared within the past 5 years;
* (6) Previously experienced sensory or motor neuropathy (Grade ≥ 2) ;
* (7) The researchers evaluate that the uncontrolled serious medical diseases that will affect the ability of the participants to receive the treatment of the clinical trial, such as complicated with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc;
* (8) known to be allergic to paclitaxel;
* (9) Received other experimental drugs or participated in clinical studies for other anti-cancer treatment purposes within 30 days of the first chemotherapy administration;
* (10) Serious infections occurring within 4 weeks prior to the start of research treatment, including but not limited to complications of infection requiring hospitalization, bacteremia, or severe pneumonia;
* (11) Human immunodeficiency virus (HIV) positive individuals;
* (12) Uncontrolled or active viral hepatitis or infection with human immunodeficiency virus;
* (13) Researchers determine that it is not suitable to participate in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06426056
Study Brief:
Protocol Section:
NCT06426056