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Clinical trial design for non-muscle-invasive bladder cancer.

作者信息

Tan Wei Shen, Hall Emma, Kamat Ashish M, Kelly John D

机构信息

Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Division of Surgery & Interventional Science, University College London, London, UK.

出版信息

Nat Rev Urol. 2023 Oct;20(10):575-576. doi: 10.1038/s41585-023-00789-0.

DOI:10.1038/s41585-023-00789-0
PMID:37328547
Abstract
摘要

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本文引用的文献

1
Hyperthermic Mitomycin C in Intermediate-risk Non-muscle-invasive Bladder Cancer: Results of the HIVEC-1 Trial.高热丝裂霉素 C 在中危非肌肉浸润性膀胱癌中的应用：HIVEC-1 试验结果。
Eur Urol Oncol. 2023 Feb;6(1):58-66. doi: 10.1016/j.euo.2022.10.008. Epub 2022 Nov 23.
2
DaBlaCa-13 Study: Oncological Outcome of Short-Term, Intensive Chemoresection With Mitomycin in Nonmuscle Invasive Bladder Cancer: Primary Outcome of a Randomized Controlled Trial.DaBlaCa - 13研究：丝裂霉素短期强化化疗切除术治疗非肌层浸润性膀胱癌的肿瘤学结局：一项随机对照试验的主要结局
J Clin Oncol. 2023 Jan 10;41(2):206-211. doi: 10.1200/JCO.22.00470. Epub 2022 Oct 12.
3
用于 BCG 无应答的高危非肌肉浸润性膀胱癌的新型免疫治疗选择。
Cancer Med. 2023 Dec;12(24):21944-21968. doi: 10.1002/cam4.6768. Epub 2023 Dec 1.
Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non-muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial.
辅助性膀胱内化疗热疗与中危非肌肉浸润性膀胱癌患者的被动化疗（HIVEC-II）：一项 2 期、开放标签、随机对照试验。
Eur Urol. 2023 Jun;83(6):497-504. doi: 10.1016/j.eururo.2022.08.003. Epub 2022 Aug 20.
4
Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study.帕博利珠单抗单药治疗卡介苗（BCG）无应答的高风险非肌肉浸润性膀胱癌（KEYNOTE-057）：一项开放标签、单臂、多中心、2 期研究。
Lancet Oncol. 2021 Jul;22(7):919-930. doi: 10.1016/S1470-2045(21)00147-9. Epub 2021 May 26.
5
Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial.纳武拉非尼基因导管治疗卡介苗无应答性非肌肉浸润性膀胱癌：一项单臂、开放标签、重复剂量临床试验。
Lancet Oncol. 2021 Jan;22(1):107-117. doi: 10.1016/S1470-2045(20)30540-4. Epub 2020 Nov 27.
6
BOXIT-A Randomised Phase III Placebo-controlled Trial Evaluating the Addition of Celecoxib to Standard Treatment of Transitional Cell Carcinoma of the Bladder (CRUK/07/004).BOXIT-一项评估塞来昔布联合标准治疗方案用于治疗膀胱移行细胞癌（CRUK/07/004）的随机 III 期安慰剂对照试验。
Eur Urol. 2019 Apr;75(4):593-601. doi: 10.1016/j.eururo.2018.09.020. Epub 2018 Sep 29.
7
Radiofrequency-induced Thermo-chemotherapy Effect Versus a Second Course of Bacillus Calmette-Guérin or Institutional Standard in Patients with Recurrence of Non-muscle-invasive Bladder Cancer Following Induction or Maintenance Bacillus Calmette-Guérin Therapy (HYMN): A Phase III, Open-label, Randomised Controlled Trial.射频热化学疗法与第二次卡介苗或机构标准治疗在诱导或维持卡介苗治疗后复发的非肌肉浸润性膀胱癌患者中的疗效比较（HYMN）：一项 III 期、开放性、随机对照试验。
Eur Urol. 2019 Jan;75(1):63-71. doi: 10.1016/j.eururo.2018.09.005. Epub 2018 Sep 28.
8
Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group.非肌层浸润性膀胱癌的定义、终点指标及临床试验设计：国际膀胱癌小组的建议
J Clin Oncol. 2016 Jun 1;34(16):1935-44. doi: 10.1200/JCO.2015.64.4070. Epub 2016 Jan 25.