Dataset from A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

本研究为一项国际多中心、随机、开放标签的门诊临床试验。受试者将以1:1的比例被分配至两个治疗组之一：替西罗莫司（temsirolimus）25mg，每周一次静脉输注（IV）；或索拉非尼（sorafenib）400mg，每日两次（BID）口服（PO）。研究性药物以6周为一个给药周期，给药全程贯穿研究周期，最长可达24个月。受试者将按照肾切除术状态、舒尼替尼治疗的应答持续时间、纪念斯隆凯特琳癌症中心（MSKCC）预后分组以及肾细胞癌（RCC）肿瘤组织学类型进行分层。