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.
ANC ≥ 1.2 × 10⁹/L, platelet ≥ 100 × 10⁹/L, Hb > 8 g/dL (no transfusion/G-CSF within 14 days)
ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN (or isolated indirect hyperbilirubinaemia)
Serum creatinine ≤ 1.5 × ULN and calculated creatinine clearance ≥ 60 mL/min
INR or PT ≤ 1.5 × ULN (therapeutic low-dose anticoagulation allowed)
None
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
First Affiliated Hospital of Suzhou Medical College
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
The Affiliated Jiangning Hospital of Nanjing Medical University
Collaborator