Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer (CLASS-07)

September 16, 2025 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is a significant global health problem, especially in East Asia. With an increase in the incidences of proximal gastric cancer over the last decades, the value of total gastrectomy is more emphasized. Laparoscopic total gastrectomy (LTG) has become an attracting option for surgeons due to its well-known advantages. However, more evidence is needed to support the safety and efficacy of LTG in locally advanced gastric cancer.

Recently，a multicenter, open-label, noninferiority, randomized clinical trial (CLASS-02) launched by Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group compared the safety of LTG for clinical stage I gastric cancer with open total gastrectomy (OTG). The overall morbidity and mortality rates were 19.1% in the LTG group and 20.2% in the OTG group, which was not significantly different (rate difference, -1.1%). This study demonstrated that LTG can be safely performed by experienced surgeons for clinical stage I gastric cancer. However, there hasn't been any prospective randomized clinical trial study evaluating the safety and efficacy of LTG in advanced gastric cancer.

This CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between LTG and 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.

Study Type

Interventional

Enrollment (Estimated)

1018

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Principal Investigator:
          • Yihong Sun, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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

Exclusion Criteria:

  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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic total gastrectomy
The surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.
Procedure: Laparoscopic total gastrectomy
LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
Other Names:
  • Experimental group (LTG)
Active Comparator: Open total gastrectomy
The surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.
Procedure: Open total gastrectomy
OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
Other Names:
  • Control group (OTG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
Overall survival (OS) was defined as the time from randomization to death from any cause
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year overall survival rate
Time Frame: 3 years
# of patients who are still alive at 3 years out of all study patients
3 years
3-year disease free survival rate
Time Frame: 3 years
# of patients who are free of gastric cancer at 3 years out of all study patients
3 years
Early morbidity rate
Time Frame: 30 days
The early morbidity are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications
30 days
Early mortality rate
Time Frame: 30 days
The early mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative death
30 days
3-year recurrence pattern
Time Frame: 3 years
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
3 years
Postoperative recovery course
Time Frame: 30 days
Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Yihong Sun, MD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 2, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSGC-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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