Even though treatment modalities such as adjuvant systemic radio-chemotherapy and neoadjuvant chemotherapy (NAC) have individually have improved overall survival (OS) and progression-free survival (PFS) rates in advanced Gastric Cancer (AGC), the peritoneum still presides as a common site of treatment failure and disease recurrence. The role of hyperthermic intraperitoneal chemotherapy (HIPEC) has been acknowledged as prophylaxis for peritoneal carcinomatosis (PC) in AGC patients and in this study, we aim at investigating the safety and efficacy of the combination of neoadjuvant laparoscopic HIPEC (NLHIPEC) with NAC in the neoadjuvant phase followed by surgery of curative intent with intraoperative HIPEC followed by adjuvant chemotherapy (AC). In this multicenter Phase III randomized controlled trial, 326 patients will be randomly separated into 2 groups into a 1:1 ratio after laparoscopic exploration. The experiment arm will receive the proposed comprehensive Dragon II regimen while the control group will undergo standard R0 D2 followed by 8 cycles of AC with oxaliplatin with S-1 (SOX) regimen. The Dragon II regimen comprises of 1 cycle of NLHIPEC for 60mins at 43 ± 0.5 °C with 80 mg/m2 of Paclitaxel followed by 3 cycles of NAC with SOX regimen and after assessment, standard R0 D2 gastrectomy with intraoperative HIPEC followed by 5 cycles of SOX regimen chemotherapy. The end-points for the study are 5 year PFS, 5 year OS, peritoneal metastasis rate (PMR) and morbidity rate. This study is one of the first to combine NLHIPEC with NAC in the preoperative phase which is speculated to provide local management of occult peritoneal carcinomatosis or peritoneal free cancer cells while NAC will promote tumor downsizing and down-staging. The addition of the intraoperative HIPEC is speculated to manage dissemination due to surgical trauma. Where the roles of intraoperative HIPEC and NAC have individually been investigated, this study provides innovative insight on a more comprehensive approach to management of AGC at high risk of peritoneal recurrence. It is expected that the combination of NLHIPEC with NAC and HIPEC will increase PFS by 15% and decrease PMR after gastrectomy of curative intent. World Health Organization Clinical Trials - International Registry Platform (WHO-ICTRP) with Registration ID ChiCTR1900024552, Registered Prospectively on the 16th July, 2019.

中文翻译：

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一项多中心III期随机对照试验的研究方案，研究了新辅助化疗（NAC）与新辅助腹腔镜腹腔内高温化疗（NLHIPEC）联合R0胃切除术与术中HIPEC联合治疗晚期胃癌（AGC）的有效性：龙II试验

尽管辅助全身性放疗和新辅助化疗（NAC）等治疗方式已分别改善了晚期胃癌（AGC）的总生存（OS）和无进展生存（PFS）率，但腹膜仍是常见的治疗失败的部位和疾病复发。腹膜高温化疗（HIPEC）的作用已被认为是预防AGC患者腹膜癌（PC）的方法，在这项研究中，我们旨在研究新辅助腹腔镜HIPEC（NLHIPEC）与NAC在腹腔镜手术中的安全性和有效性新辅助阶段，然后术中用HIPEC进行手术治疗，然后进行辅助化疗（AC）。在这项多中心III期随机对照试验中，腹腔镜探查后，将326例患者按1：1比例随机分为两组。实验组将接受拟议的全面Dragon II方案，而对照组将接受标准R0 D2，然后进行8周期AC与奥沙利铂和S-1（SOX）方案。Dragon II方案包括在43±0.5°C下用80 mg / m2紫杉醇进行1轮NLHIPEC周期60分钟，然后用SOX方案进行3周期NAC，经评估后，术中用HIPEC进行标准R0 D2胃切除，然后进行5周期。 SOX方案化疗。该研究的终点是5年PFS，5年OS，腹膜转移率（PMR）和发病率。这项研究是在术前阶段将NLHIPEC与NAC结合的首批研究之一，据推测可为隐匿性腹膜癌或腹膜游离癌细胞提供局部管理，而NAC则可促进肿瘤的缩小和分期。据推测，术中HIPEC的加入可控制由于手术创伤引起的传播。在单独调查术中HIPEC和NAC的作用的情况下，本研究为腹膜复发高风险AGC的更全面管理方法提供了创新见解。预期NLHIPEC与NAC和HIPEC的组合将在治愈根治性胃切除术后将PFS增加15％，并降低PMR。世界卫生组织临床试验-国际注册平台（WHO-ICTRP），注册ID为ChiCTR1900024552，