Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374901
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment
Sponsor:
Xiangdong Cheng
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
A Multicenter Prospective Phase II Clinical Study of Tislelizumab in Combination With Chemotherapy for the Perioperative Treatment of Resectable Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive IHC2 and locally advanced gastricgastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate MPR
Detailed Description:
This study is a multicenter prospective clinical trial aimed at evaluating the efficacy and safety of Tislelizumab combined with chemotherapy in the perioperative treatment of resectable locally advanced gastric and gastroesophageal junction adenocarcinoma
A study aimed at untreated gastric and gastroesophageal junction adenocarcinoma patients with resectable locally advanced cT34aNM0 or cT4bNanyM0 according to AJCC 8th edition staging The study aimed to enroll 134 untreated resectable locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients with the primary pathological response rate MPR as the primary endpoint
The subjects need to undergo a screening period examination within 21 days before randomization to determine whether they meet the study conditions Subjects who meet the research criteria will be randomly divided into MHC - Ⅱ positive group IHC 2 and MHC - Ⅱ negative group IHC 01 based on their MHC - Ⅱ expression The MHC - Ⅱ positive group IHC 2 will be randomly divided into two groups in a 11 ratio receiving either Tislelizumab combined with chemotherapy Group A or chemotherapy Group B The MHC - Ⅱ negative group IHC 01 will be randomly divided into two groups in a 11 ratio receiving either Tislelizumab combined with chemotherapy Group C or chemotherapy Group D Randomly stratified factors include Lauren classification intestinal type vs diffuse type vs mixed type
Based on the sample size assumption of this study the proportion of MHC - Ⅱ positive population in this study should reach at least 50
A study aimed at untreated gastric and gastroesophageal junction adenocarcinoma patients with resectable locally advanced cT34aNM0 or cT4bNanyM0 according to AJCC 8th edition staging The study aimed to enroll 134 untreated resectable locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients with the primary pathological response rate MPR as the primary endpoint
The subjects need to undergo a screening period examination within 21 days before randomization to determine whether they meet the study conditions Subjects who meet the research criteria will be randomly divided into MHC - Ⅱ positive group IHC 2 and MHC - Ⅱ negative group IHC 01 based on their MHC - Ⅱ expression The MHC - Ⅱ positive group IHC 2 will be randomly divided into two groups in a 11 ratio receiving either Tislelizumab combined with chemotherapy Group A or chemotherapy Group B The MHC - Ⅱ negative group IHC 01 will be randomly divided into two groups in a 11 ratio receiving either Tislelizumab combined with chemotherapy Group C or chemotherapy Group D Randomly stratified factors include Lauren classification intestinal type vs diffuse type vs mixed type
Based on the sample size assumption of this study the proportion of MHC - Ⅱ positive population in this study should reach at least 50
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