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NCT04710758Recruiting

Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer

Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1018 (estimated)
First submitted
2 Jan 2021
Start date
20 Jan 2021
Primary completion date
31 Dec 2028
Lead sponsor
Shanghai Zhongshan Hospital
NCT number
NCT04710758

What you commit to

  • Study type: Interventional
  • Planned participants: 1018
  • From 20 Jan 2021 to the primary completion date, 31 Dec 2028
  • 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

  • Continuous systemic steroid therapy within 1 month (except for topical use)

Other illness

  • Synchronous or metachronous (within 5 years) malignancies
  • Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
  • Severe mental disease
  • Severe respiratory disease, FEV1 \< 50% of predicted
  • Unstable angina pectoris or history of myocardial infarction within 6 months
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery

Other

  • Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
  • Women during pregnancy or breast-feeding
  • Severe hepatic and renal dysfunction
  • Patients are participating or have participated in another clinical trial (within 6 months)

Who the study is looking for

  • Aged 18-75 years
  • Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
  • Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
  • Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
  • Expected survival \> 6 months
  • No invasion to Z-line;
  • BMI (Body Mass Index) \< 30 kg/m2
  • No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
  • No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
  • Preoperative performance status (ECOG,Eastern Cooperative Oncology Group) of 0 or 1
  • Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
  • Sufficient organ functions
  • Written informed consent

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
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

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