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Recruiting Not applicable

A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer

NCT06042998 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-07-07
Last updated
2023-09-21

Condition(s) studied

Gastric Cancer Stage IIGastric Cancer Stage III

Investigational drug(s) / intervention(s)

Robotic radical gastrectomy

Robotic radical gastrectomy: Laparoscopic gastrectomy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • 3-year disease-free survival — three years after surgery
    3-year disease-free survival

Trial sites (1)

FacilityCityRegionStatus
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital Qingdao Shandong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06042998 on ClinicalTrials.gov ↗ ← All trials in China