Perioperative Adebrelimab for Locally Advanced Cervical Cancer

Ki vehet részt

• Aged 18 to 75 years
• Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix; FIGO 2018 stage IB3 or IIA2, or carefully selected stage IIB or IIIC1r disease following multidisciplinary team evaluation, with a maximum primary tumor diameter ≥4 cm. For participants with stage IIB or IIIC1r disease, PET/CT or an equivalent staging examination must exclude para-aortic lymph node metastasis and distant metastasis, and definitive concurrent chemoradiotherapy must remain feasible if neoadjuvant treatment is ineffective
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Able to provide adequate tumor tissue for biomarker testing, defined as at least 18 qualified tissue sections
• No prior surgery for cervical cancer, except staging procedures, and no prior radiotherapy, chemotherapy, systemic anticancer therapy, investigational therapy, or immunotherapy for cervical cancer
• At least one measurable lesion according to RECIST version 1.1, defined as a tumor lesion with a longest diameter ≥10 mm on CT or a lymph node with a short-axis diameter ≥15 mm on CT
• Estimated life expectancy ≥6 months
• No primary or metastatic central nervous system disease
• Adequate major organ function, meeting all of the following criteria:
• No blood or blood-product transfusion within 14 days before assessment
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
• Platelet count ≥80 × 10⁹/L
• Hemoglobin ≥9 g/dL
• Total bilirubin <1.5 × upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
• Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥40 mL/min calculated using the Cockcroft-Gault formula
• Positive for high-risk human papillomavirus (HPV) DNA
• Written informed consent provided and willingness to comply with protocol-required follow-up

Ki nem vehet részt

• Prior treatment with PD-1 and/or PD-L1 inhibitors, CTLA-4 antibodies, or other agents targeting immune-regulatory receptors
• Long-standing unhealed wounds or fractures; major surgery, severe traumatic injury, fracture, or ulcer within 4 weeks before initiation of study treatment
• Known hypersensitivity or allergy to any study drug
• Any active, known, or suspected autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, or hypothyroidism; vitiligo; or asthma requiring medical intervention with bronchodilators
• Congenital or acquired immunodeficiency, including HIV infection, hepatitis B, or hepatitis C
• Current use of immunosuppressive agents. Patients in a stable condition who do not require systemic immunosuppressive therapy may be eligible
• History of another malignancy, except for cured basal cell carcinoma of the skin or cervical carcinoma in situ
• History of psychotropic drug abuse with inability to discontinue such use, or presence of a psychiatric disorder
• Poorly controlled cardiac symptoms or cardiovascular disease, including New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction (LVEF) <50%; abnormal coagulation function defined as INR >1.5 or APTT >1.5 × ULN with a bleeding tendency; or an arterial or venous thromboembolic event within 6 months before the first dose of study treatment
• Considered unsuitable for participation in the study by the investigator
• Symptomatic ascites, pleural effusion, or pericardial effusion requiring therapeutic puncture or drainage. Patients whose pleural or pericardial effusion remains stable for at least 2 weeks after drainage before the first dose of study treatment may be eligible
• Central nervous system metastases
• Pregnant or breastfeeding women