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NCT06042998Recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
588 (estimated)
First submitted
2 Aug 2023
Start date
7 Jul 2023
Primary completion date
30 Dec 2024
Lead sponsor
The Affiliated Hospital of Qingdao University
NCT number
NCT06042998

What you commit to

  • Study type: Interventional
  • Planned participants: 588
  • From 7 Jul 2023 to the primary completion date, 30 Dec 2024
  • 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.

Prior treatment

  • Organ transplant recipients receiving immunosuppressive therapy;

Other illness

  • Suffering from serious mental illness;
  • History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy);
  • History of gastric surgery (excluding ESD/EMR for gastric cancer);
  • Moderate to severe renal insufficiency;
  • Have a history of other malignant diseases within 5 years;
  • Have a history of unstable angina or myocardial infarction within 6 months;
  • Have a history of cerebral infarction or cerebral hemorrhage within 6 months;
  • Have a history of continuous systemic corticosteroid therapy within one month;
  • Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy);
  • Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery;

Other

  • Pregnant or lactating women;
  • Lung function test FEV1\<50% of expected value;
  • The patient has participated or is currently participating in other clinical studies (within 6 months).

Who the study is looking for

  • 18 years old ≤ 75 years old male or female;
  • 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;
  • 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);
  • 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);
  • After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;
  • Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;
  • Preoperative ASA score I-III;
  • The expected survival period exceeds 6 months;
  • Willing and able to comply with the research protocol;
  • Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.