The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
SHR-A1904
Paclitaxel, Docetaxel, Irinotecan
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGOverall Survival
Measure description: Defined as time from randomization until the date of death due to any cause
Time frame: Until death, assessed up to approximately 2 years
Progression-free survival (PFS) by investigator assessment
Measure description: Defined as time from randomization until progression or death as assessed by the investigator
Time frame: Until progression or death, assessed up to approximately 1 year
Objective response rate (ORR) by investigator assessment
Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator
Time frame: Until progression, assessed up to approximately 1 year
Duration of response (DOR) by investigator assessment
Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator
Time frame: Until progression or death, assessed up to approximately 1 year
Disease control rate (DCR) by investigator assessment
Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator
Time frame: Until progression, assessed up to approximately 1 year
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Measure description: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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Time frame: until to 90 days after the last dose,assessed up to approximately 2 years