Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03802591
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2019-01-11
Brief Title:
A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma
Sponsor:
CStone Pharmaceuticals
Organization:
CStone Pharmaceuticals
Study Overview
Official Title:
A Multi-Center Double-Blind Randomized Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This is a phase III multi-Center randomized placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine CAPOX chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma GC or gastro-esophageal junction GEJ adenocarcinoma
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