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Stomach NeoplasmsCLASS-07NCT04710758

Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

A study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Stomach Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
Laparoscopic total gastrectomy and Open total gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,018 participants
Where
1 siteChina
Study dates
20 Jan 2021to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yihong Sun, MD contact

86-21-64041990

sun.yihong@zs-hospital.sh.cn

China1 site, 1 recruiting

  • ZhongShan hospital FuDan university

    Shanghai, Shanghai Municipality, 200032

    Yihong Sun, MD, 86-13701735406, sun.yihong@zs-hospital.sh.cn

    Yihong Sun, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Laparoscopic total gastrectomy, Open total gastrectomy
Keywords
Stomach Neoplasms, Laparoscopic total gastrectomy, Open total gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic total gastrectomyProcedure or surgery

    Also called Experimental group (LTG)

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

  • Open total gastrectomyProcedure or surgery

    Also called Control group (OTG)

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

Study groups in NCT04710758
Study groupRoleWhat they receive
Laparoscopic total gastrectomyExperimentalThe surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.
Receives: Procedure: Laparoscopic total gastrectomy
Open total gastrectomyActive comparatorThe surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.
Receives: Procedure: Open total gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: 3 years

Secondary outcomes (6)

  1. 3-year overall survival rate

    # of patients who are still alive at 3 years out of all study patients

    Measured: 3 years

  2. 3-year disease free survival rate

    # of patients who are free of gastric cancer at 3 years out of all study patients

    Measured: 3 years

  3. Early morbidity rate

    The early morbidity are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications

    Measured: 30 days

  4. Early mortality rate

    The early mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative death

    Measured: 30 days

  5. 3-year recurrence pattern

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

    Measured: 3 years

  6. Postoperative recovery course

    Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start20 Jan 2021
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,018 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04710758
Sponsor's protocol ID
ZSGC-006
Acronym
CLASS-07
Status last verified
Sep 2025
First submitted
2 Jan 2021
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Yang L, Zheng R, Wang N, Yuan Y, Liu S, Li H, Zhang S, Zeng H, Chen W. Incidence and mortality of stomach cancer in China, 2014. Chin J Cancer Res. 2018 Jun;30(3):291-298. doi: 10.21147/j.issn.1000-9604.2018.03.01.

    PubMed 30046223

  • Yamashita H, Seto Y, Sano T, Makuuchi H, Ando N, Sasako M; Japanese Gastric Cancer Association and the Japan Esophageal Society. Results of a nation-wide retrospective study of lymphadenectomy for esophagogastric junction carcinoma. Gastric Cancer. 2017 Mar;20(Suppl 1):69-83. doi: 10.1007/s10120-016-0663-8. Epub 2016 Oct 28.

    PubMed 27796514

  • Liu K, Yang K, Zhang W, Chen X, Chen X, Zhang B, Chen Z, Chen J, Zhao Y, Zhou Z, Chen L, Hu J. Changes of Esophagogastric Junctional Adenocarcinoma and Gastroesophageal Reflux Disease Among Surgical Patients During 1988-2012: A Single-institution, High-volume Experience in China. Ann Surg. 2016 Jan;263(1):88-95. doi: 10.1097/SLA.0000000000001148.

    PubMed 25647058

  • Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

    PubMed 8180768

  • Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.

    PubMed 26352529

  • Katai H, Mizusawa J, Katayama H, Takagi M, Yoshikawa T, Fukagawa T, Terashima M, Misawa K, Teshima S, Koeda K, Nunobe S, Fukushima N, Yasuda T, Asao Y, Fujiwara Y, Sasako M. Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912. Gastric Cancer. 2017 Jul;20(4):699-708. doi: 10.1007/s10120-016-0646-9. Epub 2016 Oct 7.

    PubMed 27718137

  • Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.

    PubMed 32060757

  • Lee HJ, Hyung WJ, Yang HK, Han SU, Park YK, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Hur H, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Kim MC; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT). Ann Surg. 2019 Dec;270(6):983-991. doi: 10.1097/SLA.0000000000003217.

    PubMed 30829698

  • Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.

    PubMed 26903580

  • Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.

    PubMed 31135850

  • Kawamura H, Yokota R, Homma S, Kondo Y. Comparison of invasiveness between laparoscopy-assisted total gastrectomy and open total gastrectomy. World J Surg. 2009 Nov;33(11):2389-95. doi: 10.1007/s00268-009-0208-y.

    PubMed 19760315

  • Wang W, Zhang X, Shen C, Zhi X, Wang B, Xu Z. Laparoscopic versus open total gastrectomy for gastric cancer: an updated meta-analysis. PLoS One. 2014 Feb 18;9(2):e88753. doi: 10.1371/journal.pone.0088753. eCollection 2014.

    PubMed 24558421

  • Hyung WJ, Yang HK, Han SU, Lee YJ, Park JM, Kim JJ, Kwon OK, Kong SH, Kim HI, Lee HJ, Kim W, Ryu SW, Jin SH, Oh SJ, Ryu KW, Kim MC, Ahn HS, Park YK, Kim YH, Hwang SH, Kim JW, Cho GS. A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03. Gastric Cancer. 2019 Jan;22(1):214-222. doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20.

    PubMed 30128720

  • Katai H, Mizusawa J, Katayama H, Kunisaki C, Sakuramoto S, Inaki N, Kinoshita T, Iwasaki Y, Misawa K, Takiguchi N, Kaji M, Okitsu H, Yoshikawa T, Terashima M; Stomach Cancer Study Group of Japan Clinical Oncology Group. Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401. Gastric Cancer. 2019 Sep;22(5):999-1008. doi: 10.1007/s10120-019-00929-9. Epub 2019 Feb 20.

    PubMed 30788750

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic total gastrectomy and Open total gastrectomy in people with Stomach Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yihong Sun, MD (86-21-64041990, sun.yihong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710758, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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