EBV positive tumor accounts for 8-9% of all gastric cancer (GC) patients. PD-1 antibody has been proved as third line therapy for PD-L1 positive gastric cancer. Previous studies showed that EBV(+) tumors exhibit high response to PD-1 antibody. In this phase II study, we will investigate the efficacy and safety of PD-1 antibody in EBV positive metastatic GC patients.
EBV positive metastatic GC patients who failed to standard chemotherapy will receive therapy of single agent, PD-1 antibody, SHR-1210, 200mg, every 2 weeks. The primary endpoint is response rate. Secondary endpoint is progress free survival, overall survival, safety and quality of life. Using the Simon two-stage sample size calculation, the sample size is 19. We will collect tissue and blood sample for exploratory analysis, including PD-L1 stuatus, tumor mutation burden, et al.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
PD-1 antibody (SHR-1210), 200mg, ivdrip, every 2 weeks.
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, China
Response rate
The percentage of patients whose cancer shrinks or disappears after treatment
Time frame: From first patient first visit to 6 month after last patient first visit ] Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Progression-Free Survival (PFS)
PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
Time frame: up to approximately 1 year
Overall Survival (OS)
The time from registration to death due to any cause, or censored at date last known alive.
Time frame: up to approximately 2 year
Disease Control Rate (DCR)
Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Time frame: From first patient first visit to 6 month after last patient first visit
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