This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
378
EBRT: 45-50.4Gy, Brachytherapy: 7Gy×4 or 6Gy ×5
Cisplatin 40mg/m2, qw×5
Cadonilimab (Moderate dose)+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGProgression-Free Survival(PFS) per RECIST 1.1 assessed by investigator(INV)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 55 months
Objective Response Rate (ORR) per RECIST 1.1
Assessed by investigators
Time frame: Up to approximately 55 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 55 months
Duration of Response (DOR) per RECIST 1.1
Assessed by investigators
Time frame: Up to approximately 3 years
Time to Response (TTR) per RECIST 1.1
Assessed by investigators
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1
Assessed by investigators
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EBRT: 45-50.4Gy; Brachytherapy: 6Gy×4
cisplatin 25mg/m2, qw×5
Cadonilimab (Moderate dose)×9 or half a year