A trial of YF476 in patients with type II gastric carcinoids

这是一项关于YF476在治疗ZE患者的II型类胃癌和/或ECL细胞增生/异型增生方面的有效性和安全性的第二阶段开放标签试点试验。该方案的目的是评估YF476是否可以将内窥镜下可见的II型胃癌的大小或数量减少25%；或者它是否可以改善胃类癌和/或ECL细胞增生的组织学分级。其他正在研究的疗效包括：YF476是否可以控制和维持胃酸的产生；它是否对血清生物标记物(即嗜铬粒细胞水平)有任何影响；基于GERD-HRQL的反流/消化不良症状的改善；以及当它与其他伴随药物一起用于ZES患者时是否安全和耐受性良好。了解YF476治疗对ZES患者II型胃类癌或胃ECL细胞异常生长的消退是否安全有效。 由于频繁访问NIH的次数繁琐，这项协议的积累一直很缓慢。目前，已有两名患者入选，且耐受性良好。来自前两名尚未完成研究的患者的初步结果似乎是有希望的。

This is a Phase 2, open-label, pilot trial of the efficacy and safety of YF476 in the treatment of type II gastric carcinopids and /or ECLcell hyperplasia/dysplasia in patients with ZEs. Thee purpose of this protocol is to assess if YF476 can have a 25% reduction in the size or number of endoscopically visible type II gastric carcinoids; or if it can improve histological grade of gastric carcinoids and/or ECL cell hyperplasia. Other effects being studied are: if YF476 can control and maintain gastric acid production; if it has any effect on serum biomarker (ie; chromogranin level); improvement in reflux/dyspepsia symptoms based on GERD-HRQL; and, if it safe and well tolerated when added to other concomitant medications in ZEs patients. find out whether treatment with YF476 is safe and effective at achieving regression of type II gastric carcinoid tumors, or the abnormal growth of gastric ECL cells, in patients with ZES. Due to the cumbersome number of frequent visits to the NIH, accrual for this protocol has been slow. At this time, two patients are currently enrolled and have tolerated the drug well. Preliminary results from the first 2 patients, who have not yet completed the study, appear to be promising.