Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05536102
Status:
RECRUITING
Last Update Posted:
2023-03-09
First Post:
2022-09-07
Brief Title:
The Effectiveness and Safety of XELOX and Tislelizumab PLD for Resectable Gastric Cancer LidingStudy
Sponsor:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
A Single-arm Open-label Multicenter Phase 2 Study to Evaluate XELOX Tislelizumab in Combination With Doxorubicin Hydrochloride Liposome Injection XELOXPD-1PLDas Neoadjuvant Therapy for Resectable Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2023-03
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 signle-arm multi-center open-lable phase II study The objective is to evaluate the effectiveness and safety of tislelizumab oxaliplatin capecitabine PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma
Detailed Description:
This single-arm multicenter open-label study plan to enroll patients with resectable stage III gastric adenocarcinoma to recieve tislelizumab oxaliplatin capecitabine PLD regimen for 2 or 4 cycles radical resection will be performed after neoadjuvant therapy Radiological evaluation will be performed every 2 cycles to evaluate the resectability of tumor Survival follow-up will be performed after surgery until patients withdrawal of informed consent loss to follow-up or death whichever comes first
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