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RECRUITING
NCT07056010
NA

Efficacy and Safety of Minimally Invasive D2+PAND Gastrectomy for Gastric Cancer With PAN Metastasis After Conversion Immunochemotherapy

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This is a prospective, open-label, single-center, Phase II clinical trial. Thirty patients with HER2-negative gastric adenocarcinoma or gastroesophageal junction (GEJ) cancer, presenting with PAN metastasis (No. 16 lymph nodes ≥10 mm), will be enrolled. Participants will receive four cycles of conversion immunochemotherapy with a PD-1 inhibitor (Serplulimab) combined with the SOX chemotherapy regimen (oxaliplatin and S-1). After completion of conversion therapy, patients will undergo curative minimally invasive (laparoscopic or robotic) gastrectomy with D2+PAND lymphadenectomy

Official title: Efficacy and Safety of Minimally-invasive Curative Gastrectomy and D2+PAND Lymphadenectomy for Gastric Cancer Patients With Para-aortic Lymph Node (PAN) Metastasis After Conversion Immunochemotherapy

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-11-25

Completion Date

2028-11-25

Last Updated

2025-07-09

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

curative minimally invasive gastrectomy with D2+PAND lymphadenectomy

Thirty patients with HER2-negative gastric adenocarcinoma or gastroesophageal junction (GEJ) cancer, presenting with PAN metastasis (No. 16 lymph nodes ≥10 mm), will be enrolled. Participants will receive four cycles of conversion immunochemotherapy with a PD-1 inhibitor (Serplulimab) combined with the SOX chemotherapy regimen (oxaliplatin and S-1). After completion of conversion therapy, patients will undergo curative minimally invasive (laparoscopic or robotic) gastrectomy with D2+PAND lymphadenectomy.

Locations (1)

First Affiliated Hospital of Nanjing Medical Unviersity

Nanjing, Jiangsu, China