{
  "abstract": "Introduction Gastric cancer (GC) remains a leading cause of cancer-related mortality worldwide, with most Chinese patients diagnosed at a locally advanced stage. Neoadjuvant chemotherapy (NAC) is increasingly used to improve resectability and survival. Laparoscopy-assisted distal gastrectomy (LADG) provides short-term recovery benefits compared with open distal gastrectomy (ODG), but its safety and oncologic efficacy following NAC remain uncertain. This trial aims to determine whether LADG is non-inferior to ODG in terms of long-term survival outcomes in patients with locally advanced distal gastric cancer (LAGC) after NAC.Methods and analysis This is a multicentre, randomised, controlled, non-inferiority trial conducted at high-volume GC centres in China. Eligible patients (aged 18–75 years; cT3–4a, N0/+, M0) with histologically confirmed distal gastric adenocarcinoma who have completed standard NAC will be randomised 1:1 to LADG or ODG with D2 lymphadenectomy. Surgical quality will be standardised through operative manuals, intraoperative video recording and central auditing. The primary endpoint is 3-year disease-free survival. Secondary endpoints are 3- and 5-year overall survival. A total of 998 patients (499 per arm) will be enrolled, providing 80% power to test non-inferiority with an absolute 8% margin, accounting for 15% attrition. Analyses will follow the intention-to-treat principle, with Cox models used for survival comparisons and subgroup analyses according to nodal status, tumour size and pathological response.Ethics and dissemination This trial has been reviewed and approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University (Approval No. 2025 (865), 16 July 2025). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals and international conferences, providing high-level evidence to guide the surgical management of LAGC after NAC.Trial registration number Chinese Clinical Trial Registry, ChiCTR2500109677; registered on 23 September 2025. Protocol V.2.1, dated 29 June 2025.",
  "authors": [
    {
      "affiliations": [
        "Department of General Surgery, Gastric Cancer Center & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Yidi Liang"
    },
    {
      "affiliations": [
        "Department of General Surgery, Gastric Cancer Center & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Xiaolong Chen"
    },
    {
      "affiliations": [
        "Department of General Surgery, Gastric Cancer Center & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Weihan Zhang"
    },
    {
      "affiliations": [
        "Department of General Surgery, Gastric Cancer Center & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Kun Yang"
    },
    {
      "affiliations": [
        "Department of General Surgery, Gastrointestinal Surgery, Zhongshan Hospital Fudan University, Shanghai, China"
      ],
      "name": "Xuefei Wang"
    },
    {
      "affiliations": [
        "Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital, Beijing, China"
      ],
      "name": "Ziyu Li"
    },
    {
      "affiliations": [
        "Cancer Center of Beijing Tsinghua Changgung Hospital, Beijing Tsinghua Changgung Hospital, Beijing, China"
      ],
      "name": "Guoxin Li"
    },
    {
      "affiliations": [
        "Department of General Surgery, Tangdu Hospital Fourth Military Medical University, Xi’an, Shaanxi, China"
      ],
      "name": "Xianli He"
    },
    {
      "affiliations": [
        "Department of General Surgery, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China"
      ],
      "name": "Zekuan Xu"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, Qinghai University Affiliated Hospital, Xining, Qinghai, China"
      ],
      "name": "Su Yan"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, Xiangya Hospital Central South University, Changsha, Hunan, China"
      ],
      "name": "Heli Liu"
    },
    {
      "affiliations": [
        "Department of General Surgery, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, China"
      ],
      "name": "Lu Zang"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, University of Electronic Science and Technology of China Sichuan Provincial People’s Hospital, Chengdu, Sichuan, China"
      ],
      "name": "Gaoping Zhao"
    },
    {
      "affiliations": [
        "Department of General Surgery, Chinese PLA General Hospital First Medical Center, Beijing, China"
      ],
      "name": "Bo Wei"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, Huazhong University of Science and Technology Tongji Medical College Tongji Hospital, Wuhan, Hubei, China"
      ],
      "name": "Guihua Wang"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, Huazhong University of Science and Technology Tongji Medical College Union Hospital, Wuhan, Hubei, China"
      ],
      "name": "Kaixiong Tao"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China"
      ],
      "name": "Kun Qian"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgical Oncology, Fujian Cancer Hospital, Fuzhou, Fujian, China"
      ],
      "name": "Zaisheng Ye"
    },
    {
      "affiliations": [
        "Department of General Surgery, Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, China"
      ],
      "name": "Bin Zhang"
    },
    {
      "affiliations": [
        "Department of Gastrocolorectal Surgery, General Surgery Center, The First Hospital of Jilin University, Changchun, Jilin, China"
      ],
      "name": "Quan Wang"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, Kunming Medical University First Affiliated Hospital, Kunming, Yunnan, China"
      ],
      "name": "Yujian Zeng"
    },
    {
      "affiliations": [
        "Department of General Surgery, Lanzhou University Second Hospital, Lanzhou, Gansu, China"
      ],
      "name": "Yong Fan"
    },
    {
      "affiliations": [
        "Department of General Surgery, Mianyang Central Hospital, Mianyang, Sichuan, China"
      ],
      "name": "Zhigang Deng"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China"
      ],
      "name": "Changqing Jing"
    },
    {
      "affiliations": [
        "Department of General Surgery, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China"
      ],
      "name": "Jin Zhou"
    },
    {
      "affiliations": [
        "Department of Pancreatic and Gastric Surgery, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China"
      ],
      "name": "Jingyu Deng"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery & Shanxi Province Clinical Medical Research Center for Malignant Tumors (Esophagogastric Junction Carcinoma), Changzhi People’s Hospital, Changzhi, Shanxi, China"
      ],
      "name": "Wenqing Hu"
    },
    {
      "affiliations": [
        "Department of Gastrointestinal Surgery, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China"
      ],
      "name": "Jian Zhang"
    },
    {
      "affiliations": [
        "Department of Gastric Surgery, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China"
      ],
      "name": "Xiangdong Cheng"
    },
    {
      "affiliations": [
        "Department of General Surgery, Third Military Medical University Southwest Hospital, Chongqing, China"
      ],
      "name": "Yan Shi"
    },
    {
      "affiliations": [
        "Department of General Surgery, Gastric Cancer Center & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Jiankun Hu"
    },
    {
      "affiliations": [],
      "name": "CLASS Chinese Laparoscopic Gastrointestinal Surgery Study"
    }
  ],
  "title": "Laparoscopic versus open distal gastrectomy with D2 lymphadenectomy following neoadjuvant chemotherapy for locally advanced gastric cancer (CLASS-03b): protocol for a multicentre, randomised, controlled, non-inferiority trial",
  "uid": "e8f988d9-01cc-5bc7-a0e2-624e7e8b1af4"
}