NCT05739045

Nivolumab Combined With SOX Used in the Perioperative Treatment

A Multicenter, Prospective, Phase Ⅱ Clinical Study of Nivolumab Combined With SOX in the Perioperative Treatment of Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Xiangdong Cheng · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;

Detailed description

Primary Objective * To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma; Secondary Objectives * To evaluate the major pathological response rate (mPR), R0 resection rate, lymph node status after neoadjuvant therapy (ypN stage), 3-yr-DFS, OS, and safety and tolerability of nivolumab combined with SOX in the periopera; Exploration for markers of benefit groups

Conditions

• Immune Suppression
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	nivolumab combined with SOX	nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles);

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-02-22
• Last updated: 2024-07-09

Locations

1 site across 1 country: China