The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
580
Apatinib 250mg
Camrelizumab 200mg
S-1, Oxaliplatin, q3w
Affiliated Hospital of Hebei University
Baoding, China
Pathological Complete Response (pCR)
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event-free Survival (EFS)
Time frame: Up to approximately 2 years
Major pathological response(MPR)
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Margin-free (R0) resection rate
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
DFS
Time frame: up to 2 years
OS
Time frame: up to 3 years
Downstaging of N stage
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
AEs
Time frame: Up to approximately 18 months
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Apatinib 500mg
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Xiangya Hospital Central South University
Changsha, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, China
Sichuan Cancer Hospital & Institute
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Hainan Cancer Hospital
Haikou, China
Cancer Hospital of the University of Chinese Academy of Sciences
Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
...and 13 more locations