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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
AK104(10.0 mg/kg,intravenous (IV) infusion,Q3W)maintained with no more than 1 year.
West China Second University Hospital
Chengdu, Sichuan, China
RECRUITINGProgression-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.
Time frame: Baseline up to approximately 24 months.
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.
Time frame: Baseline up to approximately 12 months.
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.
Time frame: Baseline up to approximately 12 months.
Overall survival
OS is the time from randomization to death due to any cause
Time frame: Baseline up to approximately 48 months.
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.
Time frame: Baseline up to approximately 48 months.
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