This is a study to evaluate the efficacy and safety of TQB2450 injection in the treatment of PD-L1 positive recurrent or metastatic cervical cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
TQB2450 1200mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Qilu Hospital of Shandong University
Jinan, Shangdong, China
Overall response rate (ORR) evaluated by Independent Review Committee (IRC)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.
Time frame: up to 12 months
Overall response rate (ORR) evaluated by investigator
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.
Time frame: up to 12 months
Disease Control Rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 12 months
Duration of response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 12 months
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 12 months
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 18 months
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DOR rate (≥ 6 months)
The percentage of participants achieved complete or partial remission ≥ 6 months.
Time frame: up to 12 months