NCT06597227

Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy

Comparison of Clinical Efficacy of Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After SOX Combined with Anti-PD-1 Neoadjuvant Therapy：a Prospective, Multi-center, Randomised，controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (estimated)
• Sponsor: Guihua Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer

Detailed description

Gastric cancer is one of the most common malignant tumors in China, and its morbidity and mortality rank among the top three for a long time.How to improve the survival rate of patients with advanced gastric cancer is the key to improve the prognosis.At present, neoadjuvant chemotherapy combined with immunosuppressants has a higher pathologic complete response (pCR) rate, reduce the clinical stage of tumors and improve the resection rate of radical surgery.Some studies have suggested that preserving partial gastric lymph nodes may enhance immunotherapy efficacy.Proximal radical gastrectomy versus total radical gastrectomy can reduce the scope of surgical resection and preserve some lymph nodes, which may contribute to long-term survival and improve postoperative quality of life of patients. It is expected to translate the short-term benefit of neoadjuvant immunotherapy into the benefit of patient overall survival (OS) rate.At the same time, our previous studies have shown that the methylation level of PD-L1 K162 can be used as a new indicator to predict the sensitivity of anti-PD -(L)1 immunotherapy, which is expected to be further confirmed in this clinical trial.Therefore, we plan to conduct a comparative study on the effectiveness and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy for locally advanced upper gastric cancer, which is expected to propose new changes in surgical methods for gastric cancer and a new indicator for screening the advantages of gastric cancer immunotherapy in the era of immunotherapy.

Conditions

• Locally Advanced Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Proximal radical gastrectomy	Proximal radical gastrectomy : Dissection of lymph nodes No.1,2,3a,4sa,4sb,7,8a, 9, 11p, 11dare recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: double channel anastomosis is recommended, and other anastomosis methods can be carried out according to the surgeon\'s habit.
PROCEDURE	Total radical gastrectomy	total radical gastrectomy : Dissection of lymph nodes No.1-7, 8a, 9, 11p, 11d, 12a are recommended. The tumor involved more than 3cm of esophagus and additional dissection No.19, 20, 110. Gastrointestinal reconstruction method: Roux⁃en⁃Y anastomosis is recommended

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-12-30
• Completion: 2028-12-30
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China