Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05149807
Status:
TERMINATED
Last Update Posted:
2022-02-10
First Post:
2021-11-09
Brief Title:
Clinical Study of SHR-1701 Plus Chemotherapy as Perioperative Treatment in Subjects With Gastric Cancer
Sponsor:
Suzhou Suncadia Biopharmaceuticals Co Ltd
Organization:
Suzhou Suncadia Biopharmaceuticals Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Multi-Center Phase IIIII Clinical Study of PD-L1 AntibodyTGF-βRII SHR-1701 Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin Versus Placebo Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin as Perioperative Treatment in Subjects With Resectable Gastric Cancer or Gastroesophageal Junction Cancer
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Rd strategy adjustment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center phase IIIII clinical study consisting of two stages Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate
Stage II is a randomized double-blind multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC A total of 846 treatment naïve subjects will be enrolled and primary endpoint of this stage is Independent Review Committee IRC-assessed EFS
Stage II is a randomized double-blind multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC A total of 846 treatment naïve subjects will be enrolled and primary endpoint of this stage is Independent Review Committee IRC-assessed EFS
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