NCT03755440

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer Stage IV
• EBV

Interventions

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

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-11-28
• Last updated: 2022-09-21

Locations

1 site across 1 country: China