Clinical trial · Interventional
A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer
A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Gastrectomy in Neoadjuvant Gastric Cancer Patients
NCT06042998CI-TRIAL-00069748CLASS14recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Stage II | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer Stage III | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic radical gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic group
- description
- Robotic gastrectomy
- interventionNames
- Procedure: Robotic radical gastrectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic group
- description
- Laparoscopic gastrectomy
- interventionNames
- Procedure: Robotic radical gastrectomy
Primary outcomes (1)
- measure
- 3-year disease-free survival
- timeFrame
- three years after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years old ≤ 75 years old male or female; 2. The primary gastric lesion was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma) by endoscopic biopsy histopathology; 3. Before neoadjuvant treatment, the preoperative clinical staging was confirmed to be II and III (cT2N+M0 or cT3-4a/N+M0) through gastroscopy/ultrasound gastroscopy, enhanced CT/MR, or diagnostic laparoscopic exploration (based on AJCC-8th TNM tumor staging); 4. 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy); 5. After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion; 6. Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%; 7. Preoperative ASA score I-III; 8. The expected survival period exceeds 6 months; 9. Willing and able to comply with the research protocol; 10. Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time. Exclusion Criteria: 1. Pregnant or lactating women; 2. Suffering from serious mental illness; 3. History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy); 4. History of gastric surgery (excluding ESD/EMR for gastric cancer); 5. Moderate to severe renal insufficiency; 6. Organ transplant recipients receiving immunosuppressive therapy; 7. Have a history of other malignant diseases within 5 years; 8. Have a history of unstable angina or myocardial infarction within 6 months; 9. Have a history of cerebral infarction or cerebral hemorrhage within 6 months; 10. Have a history of continuous systemic corticosteroid therapy within one month; 11. Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy); 12. Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery; 13. Lung function test FEV1\<50% of expected value; 14. The patient has participated or is currently participating in other clinical studies (within 6 months).
References
Publications (0)
Data not yet available
No reference posted for this study.