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
Year: 2025
Type: article
Study design: Study Protocol
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.
Source: BMJ Open
Authors: Yidi Liang, Xiaolong Chen, Weihan Zhang, Kun Yang, Xuefei Wang, Ziyu Li, Guoxin Li, Xianli He, Zekuan Xu, Su Yan, Heli Liu, Lu Zang, Gaoping Zhao, Bo Wei, Guihua Wang, Kaixiong Tao, Kun Qian, Zaisheng Ye, Bin Zhang, Quan Wang, Yujian Zeng, Yong Fan, Zhigang Deng, Changqing Jing, Jin Zhou, Jingyu Deng, Wenqing Hu, Jian Zhang, Xiangdong Cheng, Yan Shi, Jiankun Hu
Institutions: Sichuan University, West China Medical Center of Sichuan University, West China Hospital of Sichuan University, State Key Laboratory of Biotherapy, Fudan University, Zhongshan Hospital, Peking University Cancer Hospital, Beijing Tsinghua Chang Gung Hospital, Tang Du Hospital, Air Force Medical University, Jiangsu Province Hospital, Nanjing Medical University, Qinghai University Affiliated Hospital, Xiangya Hospital Central South University, Shanghai Jiao Tong University, Ruijin Hospital, University of Electronic Science and Technology of China, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chinese PLA General Hospital, Tongji Hospital, Huazhong University of Science and Technology, Wuhan Union Hospital, The Affiliated Yongchuan Hospital of Chongqing Medical University, Fujian Provincial Cancer Hospital, Zhengzhou University, Henan Cancer Hospital, Jilin University, First Hospital of Jilin University, Kunming Medical University, First Affiliated Hospital of Kunming Medical University, Lanzhou University Second Hospital, Mianyang Central Hospital, Shandong Provincial Hospital, Shandong First Medical University, First Affiliated Hospital of Soochow University, Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, First Affiliated Hospital Zhejiang University, Zhejiang University, Zhejiang Cancer Hospital, Army Medical University, Southwest Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W4417035356