A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer

Inclusion Criteria:

• Voluntary agreement to provide written informed consent.
• female, Age 18 -75 years.
• Predicted survival ≥ 3 month.
• Histologically and/or cytologically confirmed Squamous cell carcinoma, adenocarcinoma,adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.
• Unable to undergo curative surgery，Pior not received systemic therapy before CCRT,Including but not limited to radiotherapy, chemotherapy, immunotherapy, and biologicaltherapy,etc.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Have at least one evaluable lesion (RECIST 1.1 criteria)
• Adequate organ function, evidenced by the following laboratory results within 7 daysprior to the study treatment.
• participants are eligible to participate if they agree to the contraception use as perstudy protocol.
• Willing to adhere to the study visit schedule and the prohibitions and restrictionsspecified in this protocol.

Exclusion Criteria:

• Has received other antitumor therapy before CCRT.
• Therapeutic evaluation of CCRT was disease progression.
• Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies,anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (suchas ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumorimmune mechanisms treatment .
• With brain metastases.
• Previously received allogeneic stem cell or parenchymal organ transplantation.
• Previously or currently suffering from congenital or acquired immunodeficiencydiseases.
• known or suspected to have a history of allergies to similar drugs, or has a historyof hypersensitivity to chimeric or humanized antibodies or fusion proteins, or isallergic to excipients of the study drug.
• Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, orHIVAb positive.
• Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
• Within the 6 months prior to enrollment, has serious cardiovascular events such aspulmonary embolism, acute myocardial infarction, congestive heart failure (New YorkHeart Association grade III or IV), and ≥ 2 grade ventricular arrhythmias.
• Cerebrovascular accident within 6 months prior to enrollment.
• Active infection requiring systemic treatment.
• Uncontrolled hypertension, diabetes, Interstitial lung Disease, non infectiouspneumonia , pulmonary fibrosis, acute lung disease, etc.
• Required systemic treatment with glucocorticoid (>10 mg/day of prednisone orequivalent glucocorticoid) or other immunosuppressive agents within 14 days prior toenter the trial.
• History of other malignancy within the previous 5 years, except for appropriatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers witha similar curative outcome as those mentioned above.
• Has a history or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the trial, interfere with the subject'sparticipation for the full duration of the trial, or is not in the best interest ofthe subject to participate, in the opinion of the treating investigator.
• Pregnancy or lactation.
• Assessed by the investigator to be unable or unwilling to comply with the requirementsof the protocol.