背景和 S1602 更新：一项评价卡介苗菌株差异和皮内卡介苗免疫在卡介苗初治高分级非肌层浸润性膀胱癌膀胱内治疗前对 T 细胞诱导影响的 III 期随机试验
Background and Update for S1602 "A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naïve High-grade Non-muscle-invasive Bladder Cancer.
机构信息
Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA.
SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
出版信息
Eur Urol Focus. 2018 Jul;4(4):522-524. doi: 10.1016/j.euf.2018.08.015. Epub 2018 Sep 6.
Abstract
The S1602 Intergroup trial is a randomized phase III clinical trial that aims to test two important hypotheses: (1) priming with intradermal bacillus Calmette-Guérin (BCG) vaccine prior to standard intravesical BCG improves response to BCG in terms of recurrence-free survival and (2) Tokyo-172 BCG strain is non-inferior to TICE BCG in terms of time to high-grade recurrence. The study was approved by the Cancer Therapy Evaluation Program of the National Cancer Institute and activated in spring 2017. Here, we provide a synopsis of the study background, design, and update of the clinical trial.
摘要
S1602 组间试验是一项随机的 III 期临床试验，旨在检验两个重要假设：（1）经皮卡介苗（BCG）疫苗预接种提高标准膀胱内 BCG 治疗的反应，表现在无复发生存率方面；（2）东京-172 BCG 株在高级别复发时间方面不劣于 TICE BCG。该研究得到了美国国立癌症研究所癌症治疗评估计划的批准，并于 2017 年春季启动。在此，我们提供了研究背景、设计和临床试验更新的概述。
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4
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