NCT07331454Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 335 (estimated)
- First submitted
- 28 Dec 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07331454
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 335
- From 1 Feb 2026 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.