Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06192186
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-11-19
Brief Title:
Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Transformation Therapy for Locally Advanced Gastric Adenocarcinoma
Sponsor:
Yang Jianjun PhD
Organization:
Xijing Hospital
Study Overview
Official Title:
The Safety and Efficacy of Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma Patients ASOG-01
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Abstract Objective Adebrelimab is a PD-L1 inhibitor The aim of this trial is to evaluate the safety and efficacy of adebrelimab combined with SOX regimen for preoperative neoadjuvant therapy in locally advanced gastric adenocarcinoma
Methods and analysis This study is a prospective single-center two-arm double-blind and randomized controlled clinical trial designed to include 110 patients with locally advanced gastric adenocarcinoma who will be randomly assigned into two groups experimental group adebrelimab combined with SOX regimen n55 and control group SOX regimen n55 The main efficacy indicators are pathological complete response rate pCR The secondary efficacy indicators are R0 resection rate safety indicators including surgical and drug treatment safety indicators disease-free survival DFS and overall survival OS
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital Xijing Hospital of Air force Military Medical University KY20232357-F-1
Methods and analysis This study is a prospective single-center two-arm double-blind and randomized controlled clinical trial designed to include 110 patients with locally advanced gastric adenocarcinoma who will be randomly assigned into two groups experimental group adebrelimab combined with SOX regimen n55 and control group SOX regimen n55 The main efficacy indicators are pathological complete response rate pCR The secondary efficacy indicators are R0 resection rate safety indicators including surgical and drug treatment safety indicators disease-free survival DFS and overall survival OS
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital Xijing Hospital of Air force Military Medical University KY20232357-F-1
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