This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
492
3mg/kg, D1,8,15,Q4w, IV infusion
100mg/m2, D1,8,15,Q4w, IV infusion
80mg/m2, D1,8,15,Q4w, IV infusion
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0
Safety and tolerability (stage 1)
Time frame: Up to 90 days from last dose
The percentages of participants discontinuing or suspending the study drug due to an AE.
Safety and tolerability (stage 1)
Time frame: Up to 90 days from last dose
Overall survival(OS)(stage 2)
Overall survival is defined as time from randomization to death due to any cause.
Time frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
Objective response rate(ORR)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Objective response rate(ORR)assessed by the investigators according to RECIST 1.1.
Time frame: up to 2 years
Disease control rate(DCR)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Disease control rate(DCR)assessed by the investigators according to RECIST 1.1.
Time frame: up to 2 years
Progression-free survival(PFS)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Progression-free survival(PFS)assessed by the investigators according to RECIST 1.1.
Time frame: up to 2 years
Tumor response rate(TRR)assessed by the investigators according to RECIST 1.1(stage 1 and 2)
Tumor response rate(TRR)assessed by the investigators according to RECIST 1.1.
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Time frame: up to 2 years
Overall survival(stage 1)
Overall survival is defined as time from randomization to death due to any cause.
Time frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
Area under the concentration-time curve (AUC ) following single dose administration of PD-1(stage 1 )
Area under the concentration-time curve (AUC ) following single dose administration of PD-1
Time frame: through study completion, an average of 2 years
Peak plasma concentration (Cmax) following single dose administration of PD-1(stage 1 )
Peak plasma concentration (Cmax) following single dose administration of PD-1
Time frame: through study completion, an average of 2 years
Steady-state trough serum concentration of multiple Dose Administration of PD-1(stage 2)
Steady-state trough serum concentrationof multiple Dose Administration of PD-1
Time frame: through study completion, an average of 2 years
Steady-state peak serum concentration of multiple Dose Administration of PD-1(stage 2)
Steady-state peak serum concentration of multiple Dose Administration of PD-1
Time frame: through study completion, an average of 2 years
Immunogenicity(stage 1 and 2)
The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).
Time frame: through study completion, an average of 2 years