NCT05715632

New Adjuvant Treatment of Locally Advanced Resectable Gastric Cancer With Carelizumab and XELOX

Prospective, Single Arm, Single Center Exploratory Study on the New Adjuvant Therapy of Camrelizumab Combined With XELOX Regimen for Locally Advanced Gastric Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of carelizumab combined with XELOX regimen in neoadjuvant treatment of locally advanced resectable gastric cancer

Detailed description

This study is a prospective, single center, single arm clinical study. This study plans to include 67 patients with locally advanced gastric adenocarcinoma who can be operated without any treatment as the study object. After signing the informed consent, they are screened to meet the inclusion criteria. After receiving the standard dose of karelizumab combined with XELOX regimen for 4 courses of treatment before surgery, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination is used to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, The patient received radical surgical treatment for gastric cancer, and continued to receive adjuvant treatment of the original scheme after the operation (the first treatment started 6 weeks ± 2 weeks after the operation, and can not exceed 3 months).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Carrelizumab combined with XELOX	Before surgery, the patient received standard dose of carrelizumab combined with XELOX regimen for 4 courses of treatment, and within 3-4 weeks after the completion of the fourth administration, preoperative imaging examination was conducted to evaluate the efficacy of new adjuvant treatment and the possibility of radical D2 resection, and to receive radical hand surgery for gastric cancer

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2023-02-08
• Last updated: 2023-07-14

Locations

1 site across 1 country: China