Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Department of Surgery, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
BMC Cancer. 2020 Mar 17;20(1):224. doi: 10.1186/s12885-020-6701-2.
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/m 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.
尽管辅助全身放化疗和新辅助化疗（NAC）等治疗方法已分别提高了晚期胃癌（AGC）患者的总生存率（OS）和无进展生存率（PFS），但腹膜仍是治疗失败和疾病复发的常见部位。腹腔内热灌注化疗（HIPEC）的作用已被认为是预防 AGC 患者腹膜癌病（PC）的方法，在这项研究中，我们旨在研究新辅助腹腔镜 HIPEC（NLHIPEC）联合 NAC 在新辅助阶段的安全性和有效性，然后进行根治性手术，术中进行 HIPEC，然后进行辅助化疗（AC）。
在这项多中心 III 期随机对照试验中，326 名患者将在腹腔镜探查后以 1:1 的比例随机分为两组。实验组将接受拟议的 Dragon II 方案，而对照组将接受标准的 R0 D2 手术，然后接受 8 个周期奥沙利铂联合 S-1（SOX）方案的 AC。Dragon II 方案包括 1 个周期的 NLHIPEC，持续 60 分钟，温度为 43±0.5°C，紫杉醇剂量为 80mg/m2，然后进行 3 个周期的 NAC，联合 SOX 方案，评估后，进行标准的 R0 D2 胃切除术，术中进行 HIPEC，然后进行 5 个周期的 SOX 方案化疗。研究的终点是 5 年 PFS、5 年 OS、腹膜转移率（PMR）和发病率。
这是首次将 NLHIPEC 与 NAC 联合应用于术前阶段的研究之一，预计可以对隐匿性腹膜癌病或腹膜游离癌细胞进行局部管理，而 NAC 将促进肿瘤缩小和降期。术中 HIPEC 的加入预计可以治疗手术创伤引起的播散。虽然单独研究了术中 HIPEC 和 NAC 的作用，但本研究提供了对高危 AGC 患者更全面的腹膜复发管理方法的创新性见解。预计 NLHIPEC 与 NAC 和 HIPEC 的联合应用将使 PFS 提高 15%，并降低根治性胃切除术后的 PMR。
世界卫生组织临床试验 - 国际注册平台（WHO-ICTRP），注册 ID ChiCTR1900024552，于 2019 年 7 月 16 日前瞻性注册。
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