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
Pathological 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.