A phase II study of perioperative treatment in gastric cancer with No.16a2/b1 lymph node metastasis: DRAGON-06 trial

• Published in: Future oncology (London, England) England), 2022-12, Vol.18 (39), p.4239-4349
• Main Authors: Lu, Sheng, Chen, Yi-Gang, Liu, Xiao-Wen, Yang, Zhong-Yin, Shi, Min, Yuan, Hong, Liu, Wen-Tao, Ni, Zhen-Tian, Yao, Xue-Xin, Hua, Zi-Chen, Feng, Run-Hua, He, Chang-Yu, Zheng, Ya-Nan, Wang, Zhen-Qiang, Sah, Birendra Kumar, Chen, Ming-Min, Zhu, Zheng-Lun, Li, Chen, Zhang, Jun, Yan, Min, Xia, Jia-Zeng, Zhu, Zheng-Gang, Yan, Chao
• Format: Article
• Language: English
• Subjects: Antineoplastic Combined Chemotherapy Protocols - adverse effects; Clinical Trials, Phase II as Topic; Gastrectomy - adverse effects; gastric cancer; Humans; immunotherapy; intraperitoneal chemotherapy; Lymph Node Excision; Lymph Nodes - pathology; Lymphatic Metastasis - pathology; Multicenter Studies as Topic; neoadjuvant chemotherapy; overall survival; Oxaliplatin; para-aortic lymph nodes; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Stomach Neoplasms - surgery
• ISSN: 1479-6694; 1744-8301
• DOI: 10.2217/fon-2022-0718

Although gastric cancer with para-aortic lymph node (PAN) metastasis is commonly regarded as unresectable, surgeons have explored the optimal treatment for patients with PAN metastases limited to No.16a2/b1 in the past few decades. Preoperative systemic therapy combined with D2 gastrectomy plus PAN dissection may improve the prognosis of these patients. In this multicenter phase II trial, 29 gastric cancer patients with PAN metastasis limited to No.16a2/b1 will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 (nab-POS: nab-paclitaxel, oxaliplatin, S-1) and sintilimab followed by D2 gastrectomy plus PAN dissection; and postoperative treatment with oral S-1, intravenous sintilimab and intraperitoneal paclitaxel. The end points for the study are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events. Stomach cancer with metastases in the para-aortic lymph nodes is usually considered inoperable. Chemotherapy combined with resection of the stomach and more extensive lymph node dissection may prolong the life of these patients. In this multicenter study, 29 stomach cancer patients with para-aortic lymph node metastases will receive preoperative treatment with nab-paclitaxel, oxaliplatin, S-1 and sintilimab, followed by resection of the stomach combined with para-aortic lymph node dissection and use of continued oral, intravenous and intraperitoneal chemotherapy. The study’s end points are 3-year overall survival, 3-year disease-free survival, pathological response rate, incidence of postoperative complications and adverse events. ( )