This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Camrelizumab 200mg
Apatinib 250mg
S-1, Oxaliplatin, q3w
Sichuan Cancer Hospital & Institute
Chengdu, China
Changhai Hospital
Shanghai, China
Yantai Yuhuangding Hospital
Yantai, China
Pathological Complete Response (pCR)
Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a)
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Major pathological response (MPR)
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
total Pathologic complete response (tpCR)
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Pathologic Nodal Stage after Neoadjuvant Therapy
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 3 years
Disease-free survival (DFS)
Time frame: Up to approximately 3 years
Overall survival(OS)
Time frame: Up to approximately 5 years
AEs
Time frame: Up to approximately 18 months
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