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.
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. Clinical Trial Registration: ChiCTR2200061125 (ChiCTR.org.cn).
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. Clinical Trial Registration: ChiCTR2200061125 (ChiCTR.org.cn).
摘要：
尽管伴有主动脉旁淋巴结（PAN）转移的胃癌通常被认为是不可切除的，在过去的几十年中，外科医生已经探索了PAN转移患者的最佳治疗方法，仅限于16a2/b1。术前全身治疗联合D2胃切除术加PAN清扫术可以改善这些患者的预后。在这项多中心II期试验中，29例PAN转移局限于16a2/b1号的胃癌患者将接受nab-紫杉醇术前治疗，奥沙利铂,S-1（nab-POS：nab-紫杉醇，奥沙利铂,S-1）和sintilimab，然后进行D2胃切除术加PAN切除术；术后口服S-1，静脉注射sintilimab和腹膜内紫杉醇治疗。研究的终点是3年总生存期，3年无病生存期,病理反应率，术后并发症和不良事件的发生率。
主动脉旁淋巴结转移的胃癌通常被认为是不可手术的。化疗结合胃切除和更广泛的淋巴结清扫术可以延长这些患者的生命。在这项多中心研究中，29例主动脉旁淋巴结转移的胃癌患者将接受nab-紫杉醇术前治疗，奥沙利铂,S-1和sintilimab，然后切除胃结合主动脉旁淋巴结清扫术，并使用持续口服，静脉和腹膜内化疗。该研究的终点是3年总生存期，3年无病生存期,病理反应率，术后并发症和不良事件的发生率。临床试验注册:ChiCTR2200061125(ChiCTR.org.cn)。
主动脉旁淋巴结转移的胃癌通常被认为是不可手术的。化疗结合胃切除和更广泛的淋巴结清扫术可以延长这些患者的生命。在这项多中心研究中，29例主动脉旁淋巴结转移的胃癌患者将接受nab-紫杉醇术前治疗，奥沙利铂,S-1和sintilimab，然后切除胃结合主动脉旁淋巴结清扫术，并使用持续口服，静脉和腹膜内化疗。该研究的终点是3年总生存期，3年无病生存期,病理反应率，术后并发症和不良事件的发生率。临床试验注册:ChiCTR2200061125(ChiCTR.org.cn)。
