Whole exome sequencing identifies clinically relevant mutational signatures in resected hepatocellular carcinoma

We conducted a multicentre pilot study on patients with localized HCC following complete radiological response to surgical resection. Patients received 250 mg oral gefitinib once daily as adjuvant therapy, up to a maximum of 6 months. The clinical endpoints included recurrence-free survival (RFS) and overall survival (OS), and correlative genetic analyses were conducted from whole exome sequencing data (n=33). All statistical analyses were carried out on an intention-to-treat basis. The study is registered with ClinicalTrials.gov (NCT00282100).EGA study EGAS00001004371

本研究针对经手术切除后获得影像学完全缓解的局部性肝细胞癌（Hepatocellular carcinoma, HCC）患者开展了一项多中心预试验。患者接受每日一次口服250mg吉非替尼（gefitinib）作为辅助治疗，最长给药时长为6个月。本研究的临床终点包括无复发生存期（RFS）与总生存期（OS），并基于全外显子组测序数据开展了相关遗传分析（样本量n=33）。所有统计分析均按意向性治疗（intention-to-treat）原则进行。本研究已在ClinicalTrials.gov注册（注册号：NCT00282100），对应的EGA研究编号为EGAS00001004371。