This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
2.5 mg/kg intravenous infusion every 2 weeks
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
3.0 mg/kg intravenous infusion every 2 weeks
Beijing Cancer Hospital
Beijing, China
Objective response rate (ORR)
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).
Time frame: Up to approximately 2 years
Safety(adverse event)
to evaluate safety including adverse event rate and adverse event grade.
Time frame: Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Time frame: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Time frame: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Time frame: Up to approximately 2 years
Disease Control Rate(DCR)
DCR is the proportion of subjects with optimal overall response to achieve objective remission or stable disease over the course of the study
Time frame: Up to approximately 2 years
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130mg/m2 intravenous infusion Q3W
1000mg/m2 per os Q3W
2.0 mg/kg intravenous infusion every 2 weeks
750mg/m2 per os Q3W
100mg/m2 intravenous infusion Q3W