Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment.

Gastric Cancer Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial 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 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%. ;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT06374901
• Study type: Interventional
• Source: Zhejiang Cancer Hospital
• Contact: Xiangdong Cheng
• Phone: 13968032995
• Email: chengxd@zjcc.org.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 25, 2024
• Completion date: March 31, 2028