Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

NCT04710758 | Recruiting

• 1 other identifier: ZSGC-006
• Study Type: interventional
• Target: 1,018
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stomach Neoplasms

Keywords

Stomach Neoplasms; Laparoscopic total gastrectomy; Open total gastrectomy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) was defined as the time from randomization to death from any cause

  3 years

Secondary Outcomes (6)

• 3-year overall survival rate

  3 years

• 3-year disease free survival rate

  3 years

• Early morbidity rate

  30 days

• Early mortality rate

  30 days

• 3-year recurrence pattern

  3 years

Study Arms (2)

Laparoscopic total gastrectomy

EXPERIMENTAL

The surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.

Procedure: Laparoscopic total gastrectomy

Open total gastrectomy

ACTIVE COMPARATOR

The surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.

Procedure: Open total gastrectomy

Interventions

Laparoscopic total gastrectomy PROCEDURE

LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)

Also known as: Experimental group (LTG)

Laparoscopic total gastrectomy

Open total gastrectomy PROCEDURE

OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)

Also known as: Control group (OTG)

Open total gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Severe hepatic and renal dysfunction
• Unstable angina pectoris or history of myocardial infarction within 6 months
• History of cerebral infarction or cerebral hemorrhage within 6 months
• Continuous systemic steroid therapy within 1 month (except for topical use)
• Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
• Patients are participating or have participated in another clinical trial (within 6 months)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yihong Sun, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihong Sun, MD

CONTACT

86-21-64041990; sun.yihong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 15, 2021
• Study Start: January 20, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)