This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
550
200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
250 mg qd
80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
Affiliated Hospital, Academy of Military Medical Sciences
Beijing, China
RECRUITINGOverall Survival (OS) in PD-L1 Positive Participants.
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to 27 months
Overall Survival (OS) in All Participants.
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to 27 months
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Time frame: Up to 27 months
Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.
Time frame: Up to 27 months
Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants
TTF was defined as the time from randomization to treatment discontinuation caused by any reason.
Time frame: Up to 27 months
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
Time frame: Up to 27 months
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180 mg/m\^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants.
DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 27 months
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.
Time frame: Up to 27 months
Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.
TTR was defined as the time from randomization to the first documented evidence of CR or PR.
Time frame: Up to 27 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
Time frame: Up to 27 months
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
Time frame: Up to 27 months
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Time frame: Up to 27 months
Serum concentration of camrelizumab
Serum concentration of camrelizumab
Time frame: Up to 27 months
Plasma concentration of apatinib
plasma concentration of apatinib
Time frame: Up to 27 months