This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
720
SHR-1316 injection.
Cisplatin injection.
Carboplatin injection.
Paclitaxel injection.
SHR-1316 placebo injection.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival (PFS)
Time frame: Up to approximately 36 months.
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Time frame: Up to approximately 60 months.
3-year overall survival (OS) rate
OS rate within 3 years.
Time frame: Up to approximately 60 months.
2-year progression-free survival (PFS)
PFS within 2 years.
Time frame: Up to approximately 24 months.
Objective Response Rate (ORR)
Time frame: Up to approximately 36 months.
Duration of response (DoR)
Time frame: Up to approximately 60 months.
Local recurrence rate
Time frame: Up to approximately 36 months.
Distant metastasis rate
Time frame: Up to approximately 60 months.
The second disease progression assessed by the investigator
Time frame: Up to approximately 60 months.
Adverse events (AEs) including incidence and grade correlation with study drugs
Time frame: Up to approximately 60 months.
Rate of suspension and discontinuation due to an adverse event correlation with study drugs
Time frame: Up to approximately 60 months.
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