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Antibodies

Immunoglobulins

Immunologic Factors

SHR-1210, 200mg, ivdrip, d1, every two weeks.

PD-1 antibody (SHR-1210), 200mg, ivdrip, every 2 weeks.

PD-1 antibody (SHR-1210)

Rui-Hua Xu, MD, PhD

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.

PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.

Phase II Study of PD-1 Antibody SHR-1210 in EBV Positive Metastatic Gastric Cancer Patients.

The percentage of patients whose cancer shrinks or disappears after treatment

PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

The time from registration to death due to any cause, or censored at date last known alive.

Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.	NCT03755440	Gastric Cancer ... EBV	PD-1 antibody (...	18 Years -	Sun Yat-sen University
PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients.	NCT03755440	Gastric Cancer ... EBV	PD-1 antibody (...	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for gatric cancer