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KEYNOTE-590:帕博利珠单抗联合或不联合化疗一线治疗晚期食管癌的 III 期研究。

KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer.

机构信息

National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York Avenue, Room Y1247, New York, NY 10065, USA.

出版信息

Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.

DOI:10.2217/fon-2018-0609
PMID:30735435
Abstract

BACKGROUND

Treatment options for patients with advanced esophageal or esophagogastric junction (EGJ) cancer are limited. Current guidelines for first-line treatment of advanced esophageal or EGJ cancer recommend chemotherapy containing a platinum and a fluoropyrimidine agent. Pembrolizumab demonstrated antitumor activity in previously treated patients with advanced esophageal cancer and in patients with gastroesophageal junction cancer.

AIM

To describe the design and rationale for the randomized, double-blind, placebo-controlled Phase III KEYNOTE-590 study, which will be conducted to investigate pembrolizumab in combination with chemotherapy as first-line treatment in patients with advanced esophageal or EGJ cancer. Clinical trial registry & ID: ClinicalTrials.gov : NCT03189719.

摘要

背景

晚期食管或食管胃连接部(EGJ)癌症患者的治疗选择有限。目前,晚期食管或 EGJ 癌症一线治疗的指南建议使用含铂和氟嘧啶类药物的化疗。帕博利珠单抗在先前治疗的晚期食管癌患者和胃食管交界处癌患者中显示出抗肿瘤活性。

目的

描述随机、双盲、安慰剂对照的 KEYNOTE-590 研究的设计和原理,该研究将评估帕博利珠单抗联合化疗作为晚期食管或 EGJ 癌症患者一线治疗的疗效。临床试验注册编号:ClinicalTrials.gov:NCT03189719。

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