一项随机对照III期研究，比较初始不可切除的cIVB期或pIV期胃癌患者在化疗后出现显著反应时单纯化疗与转化手术的疗效（JCOG2301，转化研究）

Randomized controlled phase III study comparing chemotherapy alone versus conversion surgery after a remarkable response to chemotherapy in patients with initially unresectable cStage IVB or pStage IV gastric cancer (JCOG2301, Conversion study).

作者信息

Kita Ryosuke, Yasufuku Itaru, Takahashi Naoki, Mizusawa Junki, Sano Yusuke, Fukuda Haruhiko, Kurokawa Yukinori, Boku Narikazu, Terashima Masanori, Yoshikawa Takaki

机构信息

Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.

Department of Clinical Anatomy Development Studies, Gifu University Graduate School of Medicine, Gifu, Japan.

出版信息

Jpn J Clin Oncol. 2025 Mar 5;55(3):304-310. doi: 10.1093/jjco/hyae174.

DOI:10.1093/jjco/hyae174

PMID:39690810

Abstract

The standard approach for stage IV gastric cancer is palliative chemotherapy. However, despite the advancements in various chemotherapy regimens, the prognosis remains poor, highlighting the urgent need to develop more effective treatment strategies. The controversy persists regarding the integration of a local therapy including surgery in the management of unresectable stage IV gastric cancer. This randomized phase III trial aims to confirm the additional benefit of conversion surgery following palliative chemotherapy compared with palliative chemotherapy alone with respect to overall survival in patients initially diagnosed with unresectable clinical stage IVB or pathological stage IV gastric cancer after a remarkable response to chemotherapy. This study plans to enroll 126 patients from 63 institutions in Japan for 5 years, and it has been registered in the Japan Registry of Clinical Trials as jRCTs031240340 (https://jrct.niph.go.jp/latest-detail/jRCTs031240340).

摘要

IV期胃癌的标准治疗方法是姑息性化疗。然而，尽管各种化疗方案取得了进展，但预后仍然很差，这凸显了开发更有效治疗策略的迫切需求。对于在不可切除的IV期胃癌管理中纳入包括手术在内的局部治疗仍存在争议。这项随机III期试验旨在证实，对于最初诊断为不可切除的临床IVB期或病理IV期胃癌且化疗后有显著反应的患者，与单纯姑息性化疗相比，姑息性化疗后进行转化手术在总生存期方面的额外益处。本研究计划在5年内从日本63家机构招募126名患者，并且已在日本临床试验注册中心注册为jRCTs031240340（https://jrct.niph.go.jp/latest-detail/jRCTs031240340）。