生物标志物阳性的晚期胃癌新药临床试验设计及审评考量

Clinical trial design and evaluation consideration of new drugs for advanced gastric cancer with positive biomarker

胃癌是我国高发的消化系统恶性肿瘤,具有高度的异质性,晚期胃癌患者的生存时间短,随着近年来生物分子检测等技术的革新,分子分型成为胃癌诊断的重要内容,同时根据不同的分子特征,治疗呈现了多样化的特点。本文主要基于晚期胃癌中研发火热的抗人表皮生长因子受体-2(HER-2)药物和免疫检查点抑制药在国内外的研发情况,提出在生物标志物阳性的晚期胃癌的新药研发中,在生物标志物选择、临床实验设计、终点选择等方面需重点关注的问题,以期对基于生物标志物在晚期胃癌中的新药临床研发提供参考。

Gastric cancer is a high incidence malignant tumor of digestive system in China,with high heterogeneity.The survival time of patients with advanced gastric cancer is short.With the innovation of biomolecular detection and other technologies in recent years,molecular typing has become an important part of gastric cancer diagnosis.At the same time,according to different molecular characteristics,treatment has shown a variety of characteristics.This paper is mainly based on the research and development of the anti Human Epidermal growth factor receptor 2(HER-2) drugs and immunocheckpoint inhibitors in advanced gastric cancer,and puts forward the issues that need to be focused on in the selection of biomarkers,clinical experiment design,endpoint selection and other aspects in the research and development of new drugs for advanced gastric cancer with positive biomarkers,hoping to provide reference for the clinical research and development of new drugs for advanced gastric cancer based on biomarkers.