Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

Inclusion Criteria:

1. Locally advanced (2018 FIGO staged IB3, IIA2 and IIB（tumor size> 4cm) ) cervicalcancer，staging determined by two physicians of associate seniority or higher aftergynecologic examination and imaging evaluation);

2. At least one measurable lesion at baseline according to RECIST 1.1 criteria, withlesion size based primarily on magnetic resonance imaging;

3. Pathologically confirmed diagnosis of cervical cancer, including cervical squamouscell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma;

4. Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;

5. Patient age ≥18 years and ≤70 years;

6. ECOG score ≤1;

7. Laboratory tests: WBC (white blood cell count) ≥ 3.5×109/L, NEU (neutrophil count) ≥ 1.5×109/L, PLT (platelet count) ≥ 100×109/L, total bilirubin ≤ 1.5 times the upperlimit of normal, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 1.5 times the upper limit of normal, serum creatinine (BUN) ≤ 1.5 times the upperlimit of normal or creatinine clearance ≥ 50 mL/min (calculated using theCockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaborationequation, or the Modification of Diet in Renal Disease equation);

8. Be willing to follow up and good compliance;

9. Be willing to sign the informed consent, including compliance with the requirementsand restrictions listed in the informed consent and program；

10. Agree to use effective contraception measures during the trial period and for 5months after the last dose of pembrolizumab or 6 months after chemotherapy (whichever is longer).

Exclusion Criteria:

1. Any active autoimmune disease or history of autoimmune disease requiring systemictreatment, including but not limited to autoimmune hepatitis, interstitialpneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis,nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilatorintervention;

2. Prior treatment with immune checkpoint inhibitors, including but not limited toother anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any componentof the study medication or other monoclonal antibodies;

3. Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive, andHCV-RNA above the lower limit of detection of the assay);

4. Receipt of immunosuppressive medications or systemic corticosteroid therapy forimmunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior tostudy dosing;

5. Diagnosed with another primary malignancy within 5 years prior to the first use ofthe investigational drug;

6. Received other investigational drugs/treatments or participated in another clinicaltrial within 4 weeks prior to randomization. Participation in observational andnon-interventional clinical trials is allowed;

7. Pregnant or breastfeeding female patients;

8. Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe/unstable angina pectoris, myocardial infarctionwithin ≤ 6 months prior to study drug administration, severe arrhythmias requiringmedication or intervention; difficult-to-control hypertension; cerebral vascularaccidents or brain disorders within ≤ 6 months prior to study drug administration,or individuals with adjudicated abnormal behavioral skills; hematologic disorders:coagulation abnormalities (INR >2. 0, PT>16s), bleeding tendency, or undergoingthrombolytic or anticoagulant therapy; abnormalities in hepatic or renal developmentor a history of surgery; and development of an active infection requiring systemicanti-infective therapy within 14 days prior to the first dose of study drug;

9. Treatment with a live or attenuated vaccine administered within 4 weeks prior to thefirst dose of study drug; inactivated seasonal influenza virus vaccine is permitted;

10. Patients with a prior allogeneic bone marrow or solid organ transplant;

11. Drug and/or alcohol abuse;

12. Patients who, in the opinion of the investigator, are unlikely to comply with theprocedures, restrictions, and requirements of the study may not be enrolled in thestudy.