关于单一不可治愈因素晚期胃癌综合性治疗的研究

A study of comprehensive treatment for advanced gastric cancer with a single non-curable factor

在未经筛选的晚期胃癌患者中直接行原发灶或联合转移灶的减瘤手术未能改善患者的生存。基于一些Ⅱ期研究以及Ⅲ期研究中的亚组结果分析,部分经过筛选的晚期胃癌患者接受化疗序贯手术的综合治疗模式有可能延长其生存时间。复旦大学附属中山医院牵头设计了一项"比较多西他赛、奥沙利铂及替吉奥联合化疗序贯根治性手术与单纯姑息化疗在单一不可治愈因素的HER-2阴性晚期胃癌中的疗效及安全性:随机对照Ⅲ期临床研究(Neo-REGATTA)"。此研究针对单一不可治愈因素[或为肝转移(H1),或为腹膜转移(P1),或为腹主动脉淋巴结转移(16a1/b2),或为卵巢转移]的晚期胃癌患者,首先使用DOS方案治疗4个周期后,将获得临床反应的患者随机分为手术联合化疗组和单纯化疗组,旨在观察对于高度选择的化疗敏感的晚期胃癌患者,适时进行手术干预,是否可以从中获益。

The resection of primary and metastatic lesion in unscreened advanced gastric cancer were not testified to improve the survival time. The subgroup analysis from some phase II and III studies showed that the combination of chemotherapy and sequential surgery for some highly selective advanced gastric cancer patients were likely to prolong the overall survival times. Therefore, we designed a study ＂Chemotherapy （Docetaxel, Oxaliplatine plus S-1） followed with radical resection versus chemotherapy alone in HER-2 negative advanced gastric cancer with single non-curable factor： a phase III randomized controlled study （Neo-REGATTA）＂. This study aims at a single uncurable factor of advanced gastric cancer. Patients who received four cycles of DOS regimen will be randomized into radical surgery group and chemotherapy group, if the disease is not progressive. The study is to observe the benefits of surgical intervention in highly selective advanced gastric cancer patients who are sensitive to chemotherapy.