This study will evaluate the efficacy and safety of concurrent chemoradiotherapy（CCRT）followed by cadonilimab（AK104) in high risk local advanced cervical cancer.
Participants received CCRT，efficacy evaluation of CCRT was no disease progression who maintained with AK104（10.0 mg/kg，Q3W）until drug exposure over 1 years or disease progression or intolerable toxicity.
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.
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 (such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any tumor immune mechanisms treatment .
With brain metastases.
Single group
AK104
DrugAK104（10.0 mg/kg，intravenous (IV) infusion，Q3W）maintained with no more than 1 year.
Progression-free survival
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Objective response rate assessed by Investigator
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1.
Disease control rate
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Overall survival
OS is the time from randomization to death due to any cause
Safety and adverse reactions of Cadonilimab
According to CTCAE v5.0, any adverse events that occur to all subjects during the study period will be recorded. We recorded the clinical manifestation characteristics, severity, onset time, duration, treatment method and prognosis, and determined the correlation with Cadonilimab.
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West China Second University Hospital
Lead sponsor
Affiliated Hospital of North Sichuan Medical College
Collaborator
The Affiliated Hospital Of Southwest Medical University
Collaborator
