Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04486651
Status:
UNKNOWN
Last Update Posted:
2021-01-28
First Post:
2020-07-22
Brief Title:
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
Sponsor:
Taizhou Hanzhong biomedical co LTD
Organization:
Taizhou Hanzhong biomedical co LTD
Study Overview
Official Title:
A Randomized Double-blinded Multicenter Phase III Clinical Study of HX008 Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
This is a randomized double-blinded multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction GEJ adenocarcinoma who have had tumor progression after first-line treatment with platinum andor fluropyrimidine therapy
Detailed Description:
None
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