NCT06895447

Robotic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Therapy

Efficacy and Safety of Robotic Radical Gastrectomy in Patients With Locally Advanced Gastric Cancer After Neoadjuvant Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, single-arm phase II clinical trial designed to evaluate the safety and efficacy of robotic radical gastrectomy in patients with locally advanced gastric adenocarcinoma after undergoing neoadjuvant therapy. Conducted at multiple centers, the study aims to include 40 patients confirmed via histopathological and/or cytological analysis. Eligible participants must have stage III resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma based on imaging studies such as ultrasound endoscopy, CT, or MRI. Patients will receive 3-4 cycles of neoadjuvant therapy, followed by imaging evaluations to assess the treatment response and determine eligibility for radical D2 gastrectomy. Within 2-6 weeks of the final neoadjuvant treatment cycle, eligible patients will undergo robotic radical gastrectomy. Key outcomes include post-surgical complications, pathological responses (pCR, MPR, TRG), and objective response rates (ORR), alongside disease-free survival (DFS) and overall survival (OS).

Conditions

• Gastric Cancers

Interventions

Type	Name	Description
DRUG	Pre-operative chemotherapy	Patients will undergo pre-operative drug treatment (any chemotherapy drug or immunotherapy drug are accepted).
PROCEDURE	Robotic radical gastrectomy after neoadjuvant therapy	Eligible participants must have stage III resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma based on imaging studies such as ultrasound endoscopy, CT, or MRI. Patients will receive 3-4 cycles of neoadjuvant therapy, followed by imaging evaluations to assess the treatment response and determine eligibility for radical D2 gastrectomy. Within 2-6 weeks of the final neoadjuvant treatment cycle, eligible patients will undergo robotic radical gastrectomy.

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-11-14
• Completion: 2028-12-30
• First posted: 2025-03-26
• Last updated: 2025-07-01

Locations

1 site across 1 country: China