This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1:SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGPathological Complete Response (pCR)
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Tumor Regression Grade (TRG)
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
ypN staging
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival (EFS)
Time frame: Up to approximately 4 years
Disease-free survival (DFS)
Time frame: Up to approximately 4 years
Overall survival(OS)
Time frame: Up to approximately 4 years
AEs
Time frame: Up to approximately 3 years
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