A Randomized, Double-Blinded, Placebo-Controlled Phase Iii Trial Of Hx008 Plus Irinotecan As Second-Line Treatment In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma

J. Huang, S. Luo,P. Chen, Y. Pan, Z. Zhuang,B. Liu, Y. Ling, J. Zhang, Q. Fan, H. Wang, R. Lin,H. Zhong,Z. Chen, S. Li,J. Lv,B. Cao,L. Zhao, Y. Yang,J. Tong,S. Cang

ANNALS OF ONCOLOGY（2021）

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Abstract

Standard second-line therapy for patients with recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) cancer includes taxane or irinotecan monotherapy, ramucirumab alone or in combination with paclitaxel. HX008 is a novel highly selective, fully humanized anti-PD-1 monoclonal antibody with an engineered Fc domain. Previous report of HX008 plus irinotecan has demonstrated promising efficacy and manageable safety profile in patients with advanced G/GEJ adenocarcinoma. A phase III trial has been conducted to evaluate the efficacy and safety of HX008 plus irinotecan versus placebo plus irinotecan as second-line treatment in patients advanced G/GEJ adenocarcinoma.

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Key words

advanced gastric,junction adenocarcinoma,irinotecan,hx008,double-blinded,placebo-controlled,second-line

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