D2胃切除术联合肝脏射频消融术与单纯化疗治疗不可切除的同步性肝转移晚期胃癌疗效比较：一项多中心随机对照试验方案

Comparison of the Efficacy of D2 Gastrectomy Plus Liver Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone in the Treatment of Advanced Gastric Cancer With Unresectable Synchronous Liver Metastases: A Multicenter Randomized Controlled Trial Protocol.

作者信息

Wang Weidong, Gao Ruiqi, Yu Pengfei, Mo Zhenchang, Dong Danhong, Yang Xisheng, Li Xiaohua, Ji Gang

机构信息

Department of Digestive Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.

出版信息

Front Oncol. 2022 Feb 28;12:802683. doi: 10.3389/fonc.2022.802683. eCollection 2022.

DOI:10.3389/fonc.2022.802683

PMID:35296006

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8918569/

Abstract

BACKGROUND

Whether patients with advanced gastric cancer with unresectable synchronous liver metastases require surgical treatment remains a controversial topic among surgeons. Recently, an open-label multicenter, international RCT study show that compared with chemotherapy alone, gastric resection combined with chemotherapy had no survival advantage for advanced gastric cancer with unresectable synchronous liver metastases. A limitation of this study was that gastrectomy for gastric cancers was restricted to D1 lymphadenectomy and no metastatic lesions were removed. Whether D2 gastrectomy plus liver radiofrequency plus postoperative chemotherapy could provide benefits to these patients is worthy of further confirmation by high-level evidence-based medicine.

METHODS/DESIGN: This study will investigate the efficacy of D2 gastrectomy plus liver radiofrequency plus postoperative chemotherapy compared to chemotherapy alone in a prospective, multicenter, randomized controlled trial that will enroll 200 patients who have advanced gastric cancer with unresectable synchronous liver metastases. The patients will be randomly divided into two groups: the test group (D2 gastrectomy plus liver radiofrequency plus postoperative chemotherapy, n=100) and the control group (chemotherapy alone, n=100). The patients' general information, past medical history, laboratory tests, imaging results, surgery details, and chemotherapy details will be recorded and analysed. The overall survival (OS) will be recorded as primary endpoints. Progression-free survival (PFS) and the total incidence of complications will be recorded as secondary endpoints.

DISCUSSION

This study is to establish a multicentre randomized controlled trial to compare the efficacy of D2 gastrectomy plus liver radiofrequency combined with postoperative chemotherapy versus chemotherapy alone.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, Approved No. of ethics committee:ChiECRCT20200331. Registered on 15 November 2020. Registration number:ChiCTR2000039964. The study has received full ethical and institutional approval.

ADVANTAGES AND LIMITATIONS OF THIS STUDY

This is the first clinical trial that will provide evidence on the efficacy of D2 gastrectomy plus liver radiofrequency combined with chemotherapy versus chemotherapy alone for the treatment of advanced gastric cancer with unresectable synchronous liver metastases. A prospective RCT with 200 patients who have advanced gastric cancer with unresectable synchronous liver metastases.

CLINICAL TRIAL REGISTRATION

[https://www.chictr.org.cn/], identifier ChiCTR2000039964.

摘要

背景

对于伴有不可切除同步肝转移的晚期胃癌患者是否需要手术治疗，在外科医生中仍是一个有争议的话题。最近，一项开放标签的多中心国际随机对照试验研究表明，与单纯化疗相比，胃切除术联合化疗对于伴有不可切除同步肝转移的晚期胃癌患者并无生存优势。这项研究的一个局限性在于，胃癌的胃切除术仅限于D1淋巴结清扫，且未切除转移灶。D2胃切除术联合肝脏射频消融术加术后化疗能否使这些患者获益，值得通过高级别的循证医学进一步证实。

方法/设计：本研究将在一项前瞻性、多中心、随机对照试验中，调查D2胃切除术联合肝脏射频消融术加术后化疗与单纯化疗相比的疗效，该试验将纳入200例伴有不可切除同步肝转移的晚期胃癌患者。患者将被随机分为两组：试验组（D2胃切除术联合肝脏射频消融术加术后化疗，n = 100）和对照组（单纯化疗，n = 100）。将记录并分析患者的一般信息、既往病史、实验室检查、影像学结果、手术细节和化疗细节。总生存期（OS）将作为主要终点进行记录。无进展生存期（PFS）和并发症总发生率将作为次要终点进行记录。