To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Sintilimab 200mg, iv, 30-60min, q3w;
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGORR
Time frame: up to two years
DCR
disease control rate
Time frame: up to three years
DOR
duration of response
Time frame: up to three years
AE
treatment related adverse event
Time frame: from first dose to 90days of last dose
PFS
progression free survival
Time frame: up to three years
OS
overall survival
Time frame: up to three years
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