This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with recurrent or metastatic cervical cancer who have failed platinum-containing chemotherapy and PD-1/L1 inhibitor therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
412
SYS6002,intravenous injection
Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic cervical cancer, including topotecan (1.2 mg/m\^2 of by IV on Days 1 to 5, every 21 days), gemcitabine (1000 mg/m\^2 by IV on Days 1 and 8, every 21 days), pemetrexed (500 mg/m\^2 by IV on Day 1, every 21 days), or docetaxel (75 mg/m\^2 by IV on Day 1, every 21 days).
Overall Survival
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive
Time frame: Up to 3.5 years
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Time frame: Up to 3.5 years
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: Up to 3.5 years
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Time frame: Up to 3.5 years
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Time frame: Up to 3.5 years
Incidence of adverse events
Time frame: Up to 3.5 years
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 3.5 years
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Blood concentration of SYS6002
Time frame: Up to 3.5 years