The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
SHR-1316(Adebrelimab Injection)
Cisplatin Injection/Carboplatin Injection
External Beam Radiotherapy (EBRT)/Brachytherapy
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Type, incidence and grade of drug-related adverse events of grade 3 and above
Time frame: Up to approximately 24 months
Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs
Time frame: Up to approximately 30 months
Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug
Time frame: Up to approximately 30 months
Objective Response Rate(ORR)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 60 months
Duration of response (DoR)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 60 months
Progression free survival (PFS)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 60 months
Overall Survival (OS)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 60 months
2-year Progression free survival
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 24 months
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Paclitaxel Injection.
3-year Overall Survival
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 36 months
12-week Complete Response
judged based on RECIST 1.1 criteria according to Investigator's assessment
Time frame: Up to approximately 4 months
PK traits of SHR-1316: Cmax
Time frame: Up to approximately 24 months
PK traits of SHR-1316: Tmax
Time frame: Up to approximately 24 months
PK traits of SHR-1316: AUC0-t
Time frame: Up to approximately 24 months
PK traits of SHR-1316: AUC0-∞
Time frame: Up to approximately 24 months
PK traits of SHR-1316: t1/2
Time frame: Up to approximately 24 months
PK traits of SHR-1316: CL
Time frame: Up to approximately 24 months
PK traits of SHR-1316: Vss
Time frame: Up to approximately 24 months
Serum concentration of SHR-1316 at each planned blood collection time point
Time frame: Up to approximately 24 months