Gastric Cancer (GC)
Conditions
Keywords
gastric cancer, robotic gastrectomy, laparoscopic gastrectomy
Brief 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.
Interventions
PROCEDURERobotic 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.
PROCEDURELaparoscopic Gastrectomy
Radical gastrectomy procedure (distal or total) performed with conventional laparoscopic instruments, including the same mandatory D2 lymph-node dissection and R0 resection criteria.
Sponsors
First Affiliated Hospital of Suzhou Medical College
The Affiliated Hospital of Xuzhou Medical University
The Affiliated Jiangning Hospital of Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a parallel-group, superiority, open-label, multicenter randomized controlled trial. After central eligibility confirmation, participants are allocated 1:1 to robot-assisted or laparoscopy-assisted radical gastrectomy via a web-based block-randomization system stratified by center and intended extent of gastrectomy (distal vs total). Both arms receive standardized D2 lymph-node dissection aiming for R0 resection; post-operative care and adjuvant chemotherapy are delivered per local guidelines and recorded prospectively. Surgeons must hold ≥ 40 independent robotic/laparoscopic gastrectomy credentials, and operative videos are reviewed quarterly to ensure protocol fidelity. Cross-over is not permitted; conversion to open surgery is captured as a secondary safety endpoint. The model allows direct comparison of long-term oncologic efficacy while preserving pragmatic surgical and oncologic practice.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Histologically confirmed gastric or Siewert type III (and selected type II) gastro-oesophageal junction adenocarcinoma, clinical stage cT4a without bulky lymph-node enlargement on contrast-enhanced CT or MRI No prior neoadjuvant chemotherapy, radiotherapy, or other anti-cancer therapy Tumour deemed amenable to R0 resection by a board-certified gastric surgeon and radiologist ECOG performance status 0-1 Estimated life expectancy ≥ 6 months Adequate organ function defined by: * 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) * TSH and free T4 within normal limits or clinically insignificant deviation BMI ≥ 18.5 kg/m² or body weight ≥ 40 kg Signed informed consent
Exclusion criteria
cT4b disease, distant metastasis, or peritoneal cytology positive for malignancy Bulky lymph-node conglomerates (\> 3 cm short axis) or N3 disease precluding D2 dissection Previous gastrectomy or major upper-abdominal surgery (except uncomplicated laparoscopic cholecystectomy) within 5 years Concurrent malignancy within 5 years (except adequately treated basal-cell carcinoma, carcinoma in situ, or stage I tumours) Gastric cancer arising from emergency presentation (bleeding, perforation, obstruction) Planned multi-visceral resection for non-oncologic indication Active bleeding diathesis; INR \> 1.5 off anticoagulants; history of grade ≥ 3 bleeding within 4 weeks Arterial or venous thrombo-embolic event within 6 months Clinically significant cardiovascular disease: NYHA class III-IV heart failure, LVEF \< 50 %, myocardial infarction or unstable arrhythmia within 6 months, QTc ≥ 450 ms (men) or ≥ 470 ms (women) Severe chronic pulmonary disease: FEV₁ \< 50 % predicted or oxygen-dependent Uncontrolled diabetes (HbA1c \> 8 %), active autoimmune disease requiring systemic immunosuppression, or corticosteroids \> 10 mg/day prednisone equivalent within 14 days Active infection requiring systemic antibiotics, HIV, hepatitis B (HBV DNA ≥ 500 copies/mL), hepatitis C, or tuberculosis Pregnancy, lactation, or fertile participants unwilling to use effective contraception Psychological disorder, substance abuse, or any condition that, in the investigator's opinion, would compromise protocol compliance or safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS | 3 years |
Countries
China
Contacts
Primary ContactHao Xu, Professor
Outcome results
None listed