This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
885
Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.
250 mg administered as continuous oral once daily (QD) of each 3-week cycle.
Beijing Cancer Hospital, Peking University
Beijing, Beijing Municipality, China
Overall survival (OS) of SHR-1210 in combination with capecitabine + oxaliplatin sequenced by SHR-1210+apatinib versus capecitabine + oxaliplatin in all subjects or programmed cell death ligand 1 (PD-L1) positive participants
Time frame: Up to 36 months after the first participant is randomized.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to approximately 36 months.
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to approximately 36 months.
Incidence and severity of adverse events (AEs)
Time frame: Up to approximately 36 months.
Incidence and severity of serious adverse events (SAEs)
Time frame: Up to approximately 36 months.
Overall survival (OS) rates at 12 months, 18 months and 24 months
Time frame: Up to approximately 12 months, 18 months and 24 months.
Progression-free Survival (PFS) rates at 6 months
Time frame: Up to approximately 6 months.
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Up to approximately 36 months.
Duration of Response (DoR) per RECIST 1.1
Time frame: Up to approximately 36 months.
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