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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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