This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
443
Camrelizumab intravenously ; Famitinib Orally
Physician's choice chemotherapy
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 3 years
Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
Time frame: up to 2 years
Objective response rate (ORR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Disease control rate (DCR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Duration of response (DOR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Time to response (TTR) assessed based on RECIST V1.1 criteria
Time frame: up to 2 years
Time to treatment failure (TTF)
Time frame: up to 2 years
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
Time frame: up to 2 years
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