1. A phase II study of perioperative treatment in gastric cancer with No.16a2/b1 lymph node metastasis: DRAGON-06 trial.
- Author
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Lu S, Chen YG, Liu XW, Yang ZY, Shi M, Yuan H, Liu WT, Ni ZT, Yao XX, Hua ZC, Feng RH, He CY, Zheng YN, Wang ZQ, Sah BK, Chen MM, Zhu ZL, Li C, Zhang J, Yan M, Xia JZ, Zhu ZG, and Yan C
- Subjects
- Humans, Lymph Node Excision, Lymphatic Metastasis pathology, Oxaliplatin, Antineoplastic Combined Chemotherapy Protocols adverse effects, Lymph Nodes pathology, Gastrectomy adverse effects, Multicenter Studies as Topic, Clinical Trials, Phase II as Topic, Stomach Neoplasms drug therapy, Stomach Neoplasms surgery, Stomach Neoplasms pathology
- Abstract
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.
- Published
- 2022
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