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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT07186868
Eligibility Criteria:
Inclusion Criteria:
* Female patients aged 18 to 75 years.
* Histologically, pathologically, or radiologically confirmed recurrent or metastatic cervical cancer.
* At least one measurable lesion as defined by RECIST 1.1 (non-nodal lesion longest diameter ≥10 mm or lymph node short axis ≥15 mm).
* ECOG performance status of 0 or 1.
* Life expectancy ≥12 weeks.
* Disease progression after receiving at least one prior anti-PD-1/PD-L1 monoclonal antibody therapy (alone or in combination).
* Adequate organ function within 14 days before enrollment:
Absolute neutrophil count (ANC) \>1.5 × 10⁹/L Platelets \>100 × 10⁹/L Hemoglobin \>100 g/L Serum total bilirubin \<1.5 × ULN ALT and AST \<3 × ULN Creatinine clearance (CCr) \>60 mL/min
* Voluntarily sign the informed consent form, able to understand and comply with study requirements.
Exclusion Criteria:
* Known allergy to any component of the study drugs.
* Prior treatment with any CTLA-4 targeting medication.
* Adverse reactions from previous anti-cancer therapy have not recovered to ≤ Grade 1 (per CTCAE v5.0) (except for toxicities without safety risk per investigator's judgment, e.g., alopecia).
* History of other malignancies within the past 5 years, except for cured malignancies.
* Severe comorbid conditions, including but not limited to:
Extensive interstitial lung disease requiring medication. Active or uncontrolled infections (e.g., tuberculosis, HIV). Decompensated liver disease, active hepatitis, or active bleeding. History of cerebrovascular accident or pulmonary embolism. Active, known, or suspected autoimmune diseases. Active infection requiring systemic anti-infective therapy.
* Ascites with depth \>5 cm measured by ultrasound or CT, OR ascites causing severe symptoms (e.g., abdominal distension, dyspnea, circulatory dysfunction) significantly impacting physical function or study safety.
* Pregnant, planning pregnancy, or lactating women.
* Any other condition deemed by the investigator as unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07186868
Study Brief:
Protocol Section:
NCT07186868