To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR).
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 cT3\~4aN+M0 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 0/1+) based on their MHC - Ⅱ expression. The MHC - Ⅱ positive group (IHC ≥ 2+) will be randomly divided into two groups in a 1:1 ratio, receiving either Tislelizumab combined with chemotherapy (Group A) or chemotherapy (Group B). The MHC - Ⅱ negative group (IHC 0/1+) will be randomly divided into two groups in a 1:1 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Preoperative treatment with Tislelizumab
Preoperative treatment with SOX/XELOX
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, China
MRP (Main pathological response)
The percentage of subjects who showed no residual tumor cells (including lymph nodes, stage ypT0N0M0) and only residual single or small focal cancer cells under the light microscope
Time frame: After operation about 2 weeks until postoperative pathology report come out.
pCR (pathologic complete response)
The percentage of subjects with a TRG grade of 0 who do not have live tumor cell residues in the primary tumor lesion
Time frame: After operation about 2 weeks until postoperative pathology report come out.
DFS (Disease free survival)
Refers to the time between the time of baseline imaging evaluation and disease recurrence or death (whichever occurs first) in disease-free subjects after surgery.
Time frame: From date of randomization until the date of first documented progression, assessed up to 100 months
OS (Overall survival)
The time between the date of enrollment and death from any cause
Time frame: From date of randomization until the date of death, assessed up to 120 months
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