This study was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
874
Adebrelimab plus S-1 and oxaliplatin
Adebrelimab blank preparation plus S-1 and oxaliplatin.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGInvestigator-assessed EFS
Assessments BY INVESTIGATORS
Time frame: About 8 years
Complete response (pCR) rate as assessed by the Pathology Review Committee (PRC)
Complete remission (pCR) rates after surgery
Time frame: About 3 years
Rate of pathologically significant response (MPR) as assessed by the Pathology Review Committee (PRC)
Pathologically significant response (MPR) rate after surgery
Time frame: About 3 years
EFS as assessed by an independent review committee (IRC)
Independent Review Committee (IRC) evaluation
Time frame: About 8 years
DFS, as assessed by investigator /IRC
Investigator /IRC assessment
Time frame: About 8 years
pCR rate by central pathological evaluation
Central pathological evaluation was studied
Time frame: About 3 years
R0 resection rate of neoadjuvant therapy evaluated by investigators in different treatment groups
Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator
Time frame: About 8 years
D2 radical resection rate of neoadjuvant therapy evaluated by investigators in different treatment groups
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Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator
Time frame: About 8 years
objective response rate (ORR) of neoadjuvant therapy evaluated by investigators in different treatment groups
Patients who did not undergo surgery for gastric or gastroesophageal junction cancer because of various conditions other than disease progression were evaluated by the investigator
Time frame: About 8 years
The incidence of adverse events (AE) were evaluated according to NCI-CTCAE 6.0
NCI-CTCAE 6.0 was used for evaluation
Time frame: About 4 years
The severity of serious adverse events (SAE) were evaluated according to NCI-CTCAE 6.0
NCI-CTCAE 6.0 was used for evaluation
Time frame: About 4 years