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.
Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer.
Age: ≥18 years old, <75 years old, both male and female are eligible.
Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy + radical surgery for curative purposes.
Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria.
Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other histological types.
Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for clinical staging assessment using the 8th edition of the AJCC gastric cancer staging criteria, or not suitable for conventional surgical methods or approaches for gastric cancer.
The subject's weight has decreased by more than 20% within 2 months before randomization.
Previous anti-tumor treatment for gastric cancer/gastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization).
Parallel
Adebrelimab plus S-1 and oxaliplatin
DrugAdebrelimab plus S-1 and oxaliplatin
Adebrelimab blank preparation plus S-1 and oxaliplatin.
DrugAdebrelimab blank preparation plus S-1 and oxaliplatin.
Investigator-assessed EFS
Assessments BY INVESTIGATORS
Complete response (pCR) rate as assessed by the Pathology Review Committee (PRC)
Complete remission (pCR) rates after surgery
Rate of pathologically significant response (MPR) as assessed by the Pathology Review Committee (PRC)
Pathologically significant response (MPR) rate after surgery
EFS as assessed by an independent review committee (IRC)
Independent Review Committee (IRC) evaluation
DFS, as assessed by investigator /IRC
Investigator /IRC assessment
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