Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03755440
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2018-11-22
Brief Title:
PD-1 Antibody in EBV Positive Metastatic Gastric Cancer Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Phase II Study of PD-1 Antibody SHR-1210 in EBV Positive Metastatic Gastric Cancer Patients
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None