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Clinical Trials in China / NCT06042998
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
Sponsor
The Affiliated Hospital of Qingdao University
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)

Trial sites (1)

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

More The Affiliated Hospital of Qingdao University trials in China

Other trials for the same condition

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