晚期胆囊癌化疗新方案有效性、安全性的随机、对照、开放、多中心临床研究

摘要

Comprehensive therapy is the leading method to improve the overall survival for patients with advanced gallbladder cancer, especially the study of new chemotherapy regimen are on demand.From 2010 to 2011, a phase Ⅲ study of new chemotherapy regimen in the treatment of advanced gallbladder carcinoma would be undertaken nationwide to assess the clinical outcome and safety, in 31 clinical centers led by the department of General Surgery of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, and a total of 260 patients would be accrued for this study.Chemotherapy consists of 2 regimes, conventional regime(cisplatin, epirubicin, and 5-fluorouracil, leucovorin)and new regime(conventional regime plus somatostatin).At present, the study has been approved by Clinical Trial Registration Platform of National Institutes of Health in U.S.A., and more than 30 patients are rolling in the study.The clinical trial could provide the high-quality evidence of EBM(evdence based medicine)for the chemotherapy of advanced gallbladder caner, and it will be one of the important components in the large-scale clinical study of chemotherapy for the advanced gallbladder cancer in China and worldwide.%化疗等综合性治疗为提高晚期胆囊癌病人总体生存状况的主要手段,选择胆囊癌敏感的化疗方案则为研究的重点.2010年至2011年,以上海交通大学医学院附属新华医院普外科为首的全国31个临床中心将入组260例晚期胆囊癌病人,采用随机对照开放的方式对晚期胆囊癌化疗新方案(Cisplatin+epirubicin+5-FU+LV联合SST)进行有效性及安全性的评价.目前此研究已获得美国国立卫生研究院临床试验注册平台批准,并成功入组30余例病人.此次临床试验将为晚期胆囊癌临床化疗提供可信的循证依据,成为我国乃至世界范围内胆囊癌化疗大型临床研究的重要组成部分之一.