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 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT06986057
Eligibility Criteria:
Inclusion Criteria:
* Voluntary signing of written Informed Consent Form (ICF).
* Age ≥18 years and ≤75 years at enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically or cytologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) with clinical staging by FIGO 2018 criteria: IB3, IIA2, IIB, or IIIC (parametrial invasion without reaching the pelvic wall, no vaginal lower third involvement).
* No prior systemic or local antitumor therapy (including radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy) for cervical cancer prior to the first dose of study treatment.
Agreement to undergo radical hysterectomy with no surgical contraindications as judged by the investigator.
* At least one untreated measurable lesion according to RECIST v1.1.
* Consent to provide tumor tissue and peripheral blood samples during the screening period and study procedures for related research.
* Adequate organ function:
a) Hematology (no blood components or growth factor support within 7 days before study treatment): i. Absolute neutrophil count (ANC) ≥1.5×10⁹/L (1,500/mm³); ii. Platelet count ≥100×10⁹/L (100,000/mm³); iii. Hemoglobin ≥90 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula); ii. Urine protein \<2+ or 24-hour urine protein \<1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Albumin (ALB) ≥28 g/L. d) Coagulation: i. INR and APTT ≤1.5×ULN (stable anticoagulation therapy allowed if parameters remain within therapeutic range).
e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥50%.
* Fertile women must have a negative urine or serum pregnancy test within 3 days before first dose. If urine test is inconclusive, serum testing is required. Contraception must be used from screening until 120 days post-treatment. Barrier methods or hormonal contraceptives (e.g., pills) are required.
1. Fertile women: Not surgically sterilized (e.g., bilateral tubal ligation) or premenopausal (≥12 months amenorrhea with FSH in postmenopausal range).
2. Effective contraception: Methods with \<1% failure rate (e.g., hormonal contraceptives).
* Willingness and ability to comply with scheduled visits, protocols, labs, and study requirements.
* Expected survival ≥6 months.
Exclusion Criteria:
* Histopathological type other than cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, sarcoma).
* History of other malignancies within 3 years prior to enrollment, excluding localized malignancies cured by local therapy (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast).
* Simultaneous enrollment in another clinical study, unless it is an observational, non-interventional study or within the follow-up period of an interventional study.
* Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor) within 2 weeks prior to first dose; herbal or proprietary Chinese medicine with antitumor indications within 1 week prior to first dose.
* Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal/pituitary insufficiency) is not considered systemic therapy.
* History of non-infectious pneumonia requiring systemic corticosteroids or current interstitial lung disease.
* Significant bleeding diathesis or coagulation dysfunction.
* Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease/gastritis, or psychiatric/social conditions impairing compliance or informed consent.
* History of myocarditis, cardiomyopathy, or malignant arrhythmias. Within 12 months prior to first dose: unstable angina, congestive heart failure, or vascular disease requiring hospitalization (e.g., surgical repair of aortic aneurysm/peripheral venous thrombosis). Within 6 months prior: esophageal-gastric varices, unhealed wounds, gastrointestinal perforation, fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding. Arterial thromboembolism, NCI CTCAE 5.0 grade ≥3 venous thromboembolism, transient ischemic attack, stroke, hypertensive crisis, or hypertensive encephalopathy. Within 1 month prior: acute exacerbation of COPD. Current hypertension uncontrolled with oral antihypertensives (SBP ≥160 mmHg or DBP ≥100 mmHg).
* Active or history of definite inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Severe infection within 4 weeks prior to first dose (including hospitalization, sepsis, or severe pneumonia). Active infection requiring systemic antimicrobial therapy within 10 days prior (excluding HBV/HCV antiviral therapy).
* Major surgery or severe trauma within 30 days prior to first dose; minor local procedures (excluding peripherally inserted central catheter placement) within 3 days prior.
History of immunodeficiency, HIV seropositivity, or current long-term systemic corticosteroid/immunosuppressant use.
* Active pulmonary tuberculosis (TB) or suspected TB requiring clinical exclusion (e.g., sputum AFB, chest X-ray).
* Active syphilis infection.
* History of allogeneic organ or hematopoietic stem cell transplantation.
* Untreated active HBV (HBsAg+ with HBV-DNA \>1000 copies/mL \[200 IU/mL\] or above limit of detection). HBV patients must receive antiviral therapy during study. Active HCV (HCV Ab+ with HCV-RNA above limit of detection).
* Live vaccine administration within 30 days prior to first dose or planned during study.
* Known hypersensitivity to any study drug component or severe allergic reaction to other monoclonal antibodies.
* History of psychiatric disorders, substance abuse, alcoholism, or drug addiction.
* Pregnancy or lactation.
* Any disease, treatment, or laboratory abnormality that may confound study results, hinder compliance, or compromise participant safety.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06986057
Study Brief:
Protocol Section:
NCT06986057