This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.
This is a randomized, double-blind, placebo-controlled phase III study,aimed to evaluate the efficacy and safety of GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
424
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGoverall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to 2 years
progression-free survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1.
Time frame: Up to 2 years
Objective Response Rate (ORR)
Proportion of subjects who have a complete or partial response relative to baseline based on RECIST 1.1 criteria.
Time frame: Up to 2 years
Duration of Response (DOR)
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: Up to 2 years
Disease Control Rate (DCR)
DCR defined as the proportion of subjects' response of CR, PR, or SD based on RECIST v1.1 criteria.
Time frame: Up to 2 years
Time to Response(TTR)
TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on RECIST v1.1 criteria.
Time frame: Up to 2 years
Number of subjects with adverse events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: From the time of signed informed consent to 90 days after end of treatment.
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IV infusion
IV infusion
IV infusion
Quality of life (QoL)
EORTC QLQ-C30 will be used.
Time frame: Up to 2 years