The purpose of this study is to evaluate the efficacy and safety of the study drug known as KH903 in participants with gastric and gastroesophageal cance
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
81
KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle; Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle; Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
Progression-free survival(PFS)
Date of randomization until the date of first documented Progression or date of death from any cause, whichever came first
Time frame: Time from date of randomization until the date of first documented Progression or date of death from any cause, whichever came frist,assessed up to18 months
Objective Response Rate (ORR)
Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)
Time frame: Time from date of randomization until the date of first documented CR or PR,assessed up to18 months
Duration of Response (DOR)
is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months
Time frame: Time from first documented evidence of CR or PR until the date of first documented progression ,assessed up to18 months
Disease Control Rate (DCR)
Percentage of Participants who have achieved CR, PR and SD to study treatment;
Time frame: Time from date of randomization until the date of first documented Progression,assessed up to18 months
AE
Number of Subjects with treatment-related adverse events (AEs)Defined by all
Time frame: AEs(NCI CTCAE 5.0) collected at each cycle,Assessed up to18 months
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