A Single-Arm Exploratory Study of Enlansibumab Sequentially Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Exclusion Criteria

• •1. There are distant metastatic diseases present;
• •2. Have received any previous anti-tumor treatment, including but not limited to surgery (excluding biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
• •3. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies;
• •4. Active malignant tumor within 3 years before the first administration, excluding cervical cancer studied in this trial and any locally curable tumor that has received radical treatment (such as excised basal cell or squamous cell skin cancer, superficial bladder cancer cancer or cured carcinoma in situ, such as breast carcinoma in situ);
• •5. Suffering from active autoimmune diseases, or having a history of autoimmune diseases within 2 years before enrollment, and still requiring systemic treatment. Autoimmune diseases include but are not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring intervention with bronchodilators;
• •6. Suffering from primary immunodeficiency disease or having a medical history;
• •7. Individuals who have received immunosuppressive therapy (such as cyclosporine) or require systemic steroid therapy (such as\>20 mg/day prednisone or equivalent) within the 14 days prior to enrollment, except for those who receive local corticosteroid therapy via nasal spray, inhalation, or other routes;
• •8. Individuals who are HIV Ab positive or have active syphilis infection; Hepatitis B virus surface antigen (HBsAg) is positive, and the detection value of hepatitis B virus is\>500IU/ml or 2500 copies/mL; Hepatitis C antibody (HCV Ab) is positive, and the hepatitis C virus RNA quantification is greater than the upper limit of the normal value of the detection unit. (Note: For those with positive hepatitis B virus surface antigen (HBsAg), antiviral treatment is recommended before the first use of the study drug, and nucleoside analogs such as entecavir and tenofovir dipivoxil are recommended. )
• •9. Active bacterial, fungal, or viral infections (defined as requiring intravenous injection of antibacterial, antifungal, or antiviral drugs for treatment) within 14 days prior to enrollment. For individuals who have no clinical manifestations of active infection before the first medication and receive prophylactic treatment for infection, they may be considered for inclusion;
• •10. Active tuberculosis or medical history;
• •11. Have experienced severe cardiovascular disease within the 6 months prior to enrollment, including but not limited to: stable angina pectoris with functional classification of III-IV; Unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; Severe arrhythmia requiring medication treatment (if ventricular rate can be controlled, asymptomatic atrial fibrillation subjects are allowed to be included); Serious arterial/venous thrombotic events (such as cerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);
• •12. Suffering from uncontrollable hypertension;
• •13. Have previously suffered from interstitial lung disease or non infectious pneumonia requiring glucocorticoid treatment;
• •14. There is clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stent placement, as determined by researchers; Within 28 days prior to enrollment or planned to receive live or attenuated vaccine treatment during the study period;
• •16\. Known recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Have a history of severe allergic reactions and uncontrolled allergic asthma to all components of monoclonal antibody preparations; 18. There are contraindications or severe allergic reactions to any component of cisplatin; 19. Individuals who have participated in other clinical trials and used the investigational drug within 28 days prior to enrollment; 20. Participants who may have poor compliance with the research procedures and requirements, as determined by the researchers, such as those with a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current mental disorders, and substance abuse; 21. Individuals with a clear history of neurological or mental disorders or drug abuse who are unable to quit or have a history of drug use; 22. There are situations where other researchers have determined that it is not suitable to participate in this experiment.