Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04710758

Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

Led by Shanghai Zhongshan Hospital · Updated on 2025-09-22

1018

Participants Needed

1

Research Sites

414 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Aged 18-75 years
  2. 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);
  3. 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;
  4. Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
  5. Expected survival > 6 months
  6. No invasion to Z-line;
  7. BMI (Body Mass Index) < 30 kg/m2
  8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
  9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
  10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
  11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
  12. Sufficient organ functions
  13. Written informed consent
Not Eligible

You will not qualify if you...

  1. Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
  2. Women during pregnancy or breast-feeding
  3. Synchronous or metachronous (within 5 years) malignancies
  4. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
  5. Severe mental disease
  6. Severe respiratory disease, FEV1 < 50% of predicted
  7. Severe hepatic and renal dysfunction
  8. Unstable angina pectoris or history of myocardial infarction within 6 months
  9. History of cerebral infarction or cerebral hemorrhage within 6 months
  10. Continuous systemic steroid therapy within 1 month (except for topical use)
  11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
  12. Patients are participating or have participated in another clinical trial (within 6 months)

AI-Screening

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Trial Site Locations

Total: 1 location

1

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Y

Yihong Sun, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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