NCT07331454

Robotic vs Laparoscopic Gastrectomy for cT4a Gastric Cancer

Robot-Assisted Versus Laparoscopy-Assisted Gastrectomy in Patients With cT4a Gastric Cancer: A Multicenter, Randomized Controlled, Phase III Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 335 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multicenter, randomized, phase III clinical trial is to test whether robot-assisted radical gastrectomy improves 3-year recurrence-free survival versus laparoscopy-assisted radical gastrectomy in adults aged 18-80 years with previously untreated, resectable cT4a gastric adenocarcinoma and non-bulky lymph nodes; the main questions are whether the robotic approach confers superior RFS and maintains equivalent peri-operative safety (Clavien-Dindo ≥ II complications) and better secondary oncologic outcomes, and participants will be randomized 1:1 to undergo standardized D2 resection via robotic or laparoscopic technique and followed for 5 years with scheduled recurrence, survival, and quality-of-life assessments.

Conditions

• Gastric Cancer (GC)

Interventions

Type	Name	Description
PROCEDURE	Robotic Gastrectomy	Radical gastrectomy (distal or total) performed with the da Vinci robotic system, including standardized D2 lymph-node dissection, aiming for R0 resection. All operative steps (lymph-node dissection, vessel ligation, digestive reconstruction) are completed with robotic instrumentation under 3-D high-definition vision and tremor-filtered wristed instruments.
PROCEDURE	Laparoscopic Gastrectomy	Radical gastrectomy procedure (distal or total) performed with conventional laparoscopic instruments, including the same mandatory D2 lymph-node dissection and R0 resection criteria.

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China