Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461910
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Efficacy and Safety of Anti-PD-1 Thymosin and SOX in Neoadjuvant Treatment of cStage III GastricGEJ Adenocarcinoma
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
The Efficacy and Safety of Anti-PD-1 Combined With Thymosin and SOX in Neoadjuvant Treatment of cStage IIII Gastric or Esophagogastric Junctional Adenocarcinoma A Prospective Open-label Single-arm Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 Phase II clinical study is a prospective open-label single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy sintilimab with thymosin α1 and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or esophagogastric junction GEJ adenocarcinoma The primary objective is to explore the therapeutic efficacy and safety of this combined treatment approach The secondary objective is to assess its impact on the tumor immune microenvironment in locally advanced gastric cancer
Study Design
The study plans to enroll 30 patients who have been pathologically confirmed as HER2-negative and diagnosed with resectable stage III gastric or GEJ adenocarcinoma Siewert type III and type II without the need for thoracotomy The study includes multiple steps
Treatment Regimen Participants will receive three cycles of sintilimab combined with the SOX regimen oxaliplatin and S-1 and nine weeks of thymosin α1 before surgery
Assessment Points Tumor response will be evaluated through imaging studies at the end of the second and third cycles of neoadjuvant therapy Post-treatment surgery is scheduled within 2-6 weeks following the last dose of the third cycle
Pathological Evaluation Surgical tumor samples will undergo pathological examination including assessments for pathological complete response pCR tumor regression grade TRG major pathological response MPR overall response rate ORR disease control rate DCR clinical downstaging rate and R0 resection rate
Safety Monitoring Adverse events will be monitored throughout the treatment period to evaluate the safety of the neoadjuvant immunochemotherapy regimen
Follow-up Patients will be followed up to calculate disease-free survival DFS and overall survival OS
Eligibility Criteria
Inclusion Criteria
i Confirmed diagnosis of HER2-negative gastric or GEJ adenocarcinoma ii Clinical stage III resectable tumors iii Adequate organ function and performance status
Exclusion Criteria
i Prior treatment with immune checkpoint inhibitors ii History of autoimmune diseases or other malignancies iii Severe comorbidities that could interfere with the study
Goals and Objectives Primary Goal To determine the effectiveness and safety of combining sintilimab with thymosin α1 and SOX as a neoadjuvant therapy
Secondary Goal To investigate changes in the tumor immune microenvironment induced by the treatment and their correlation with therapeutic efficacy
Study Implications This study aims to provide critical insights into the potential benefits of integrating immunotherapy with chemotherapy and thymosin α1 in treating locally advanced gastric cancer By focusing on both efficacy and immune microenvironment alterations the findings could pave the way for novel neoadjuvant treatment strategies and improve clinical outcomes for gastric cancer patients
Study Design
The study plans to enroll 30 patients who have been pathologically confirmed as HER2-negative and diagnosed with resectable stage III gastric or GEJ adenocarcinoma Siewert type III and type II without the need for thoracotomy The study includes multiple steps
Treatment Regimen Participants will receive three cycles of sintilimab combined with the SOX regimen oxaliplatin and S-1 and nine weeks of thymosin α1 before surgery
Assessment Points Tumor response will be evaluated through imaging studies at the end of the second and third cycles of neoadjuvant therapy Post-treatment surgery is scheduled within 2-6 weeks following the last dose of the third cycle
Pathological Evaluation Surgical tumor samples will undergo pathological examination including assessments for pathological complete response pCR tumor regression grade TRG major pathological response MPR overall response rate ORR disease control rate DCR clinical downstaging rate and R0 resection rate
Safety Monitoring Adverse events will be monitored throughout the treatment period to evaluate the safety of the neoadjuvant immunochemotherapy regimen
Follow-up Patients will be followed up to calculate disease-free survival DFS and overall survival OS
Eligibility Criteria
Inclusion Criteria
i Confirmed diagnosis of HER2-negative gastric or GEJ adenocarcinoma ii Clinical stage III resectable tumors iii Adequate organ function and performance status
Exclusion Criteria
i Prior treatment with immune checkpoint inhibitors ii History of autoimmune diseases or other malignancies iii Severe comorbidities that could interfere with the study
Goals and Objectives Primary Goal To determine the effectiveness and safety of combining sintilimab with thymosin α1 and SOX as a neoadjuvant therapy
Secondary Goal To investigate changes in the tumor immune microenvironment induced by the treatment and their correlation with therapeutic efficacy
Study Implications This study aims to provide critical insights into the potential benefits of integrating immunotherapy with chemotherapy and thymosin α1 in treating locally advanced gastric cancer By focusing on both efficacy and immune microenvironment alterations the findings could pave the way for novel neoadjuvant treatment strategies and improve clinical outcomes for gastric cancer patients
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?:
True
Is an FDA AA801 Violation?:
None