This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
205
IBI310 3 mg/kg,Q3W, for a total of 4 cycles
Placebo Q3W, for a total of 4 cycles
Sintilimab 200mg,Q3W
Innovent Biologics, Inc.
Suzhou, Jiangsu, China
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Zhenjiang, China
Objective response rate (ORR)
Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
Time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Objective response rate (ORR)
ORR assessed by the investigator according to the RECIST V1.1
Time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Disease Control Rate(DCR)
DCR assessed by the investigator and IRRC according to the RECIST V1.1
Time frame: Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
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