This study aims to evaluate the efficacy and safety of SHR-A1811 combined with chemotherapy and immune checkpoint inhibitor versus standard first-line therapy in gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
SHR-A1811: intravenous infusion; Adebrelimab Injection: intravenous infusion; Capecitabine Tablets: oral administration Fluorouracil Injection: intravenous infusion
Trastuzumab : intravenous infusion; Pembrolizumab: intravenous infusion; Capecitabine Tablets: oral administration; Oxaliplatin: intravenous infusion; Fluorouracil Injection: intravenous infusion; Cisplatin: intravenous infusion;
The First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGZhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGProgression Free Survival (PFS) per RECIST 1.1 assessed by BIRC(Blinded Independ Review Committee)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Time frame: UP to approximately 5 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: UP to approximately 5 years
Objective Response Rate (ORR) per RECIST 1.1 assessed by BIRC
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR)
Time frame: UP to approximately 5 years
PFS per RECIST 1.1 assessed by investigator
PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause.
Time frame: UP to approximately 5 years
Disease Control Rate (DCR) per RECIST 1.1
DCR is defined as the proportion of patients who exhibit no tumor progression (including shrinkage or stability) after treatment.
Time frame: UP to approximately 5 years
Duration of Response (DOR)
DOR is defined as the time from the first achievement of complete response (CR) or partial response (PR) to the first occurrence of disease progression (PD) or death from any cause.
Time frame: UP to approximately 5 years
Adverse events (AE)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: UP to approximately 5 years
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