This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD,patients will randomly 2:1 assigned to treatment:one group will receive Serpluimab with Paclitaxel,Apatinib;another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent
stage one :Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1\~d14,q3w stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Immunotherapy+chemotherapy
chemotherapy±Targeted therapy
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITING6-month PFS%
Progression-free survival by IRRC assessment per RECIST 1.1
Time frame: The Percent of patinets after first progression until disease progression in 6 months
OS
Overall survival
Time frame: From the date of first dose unitl the date of death from any cause,assessed up to 2 years ]
PFS2
Progression-free survival by IRRC assessment per RECIST 1.1
Time frame: From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first
PFS1
Progression-free survival by IRRC assessment per RECIST 1.1
Time frame: From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first
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