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The changing landscape of phase II/III metastatic sarcoma clinical trials—analysis of ClinicalTrials.gov

机译：II期II / III转移性肉瘤临床试验的变化景观 - 临床研究分析.GOV

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Well-designed clinical trials are of great importance in validating novel treatments and ensuring an evidence-based approach for sarcoma. This study aimed to provide a comprehensive landscape of the characteristics of metastatic or advanced sarcoma clinical trials using the substantial resource of the ClincialTrials.gov database. We identified 260,755 trials registered with ClinicalTrials.gov in the last 20?years, and 277 of them were eligible for inclusion. The baseline characteristics were ascertained for each trial. The trials were systematically reviewed to validate their classification into 96 trials registered before 2008 and 181 trials registered between 2008 and 2017. We found that in the last decade, metastatic and advanced sarcoma trials were predominantly phase II-III studies (p?=?0.048), were more likely to be ≥2 arms (17.7% vs 35.3%, respectively; p?=?0.007), and were more likely to use randomized (13.5% vs 30.4%; p?=?0.002) and double-blinded (2.1% vs 9.4%; p?=?0.024) assignment than trials registered before 2008. Furthermore, in the last 10-year period, metastatic sarcoma trials were more likely to be conducted in Asia. Treatment involving target therapy and immunotherapy were more common (71.8% vs 37.5%; p??0.001) than in previous years. Our data showed provocative changes in the sarcoma landscape and demonstrated that the incidence of clinical trials with target therapy and immunotherapy is increasing. These findings emphasize the desperate need for novel strategies, including target therapy and immunotherapy, to improve the outcomes for patients with advanced sarcoma.
机译：精心设计的临床试验在验证新的治疗方面具有重要意义，并确保肉瘤的循证方法。本研究旨在提供使用ClincialTrials.gov数据库的大量资源的转移性或高级肉瘤临床试验的综合景观。我们确定了260,755名试验，在最后20岁的时候在临床节中注册了260,755次试验。年份，其中277人有资格包容。每次试验确定基线特征。经过系统地审查了试验，验证其分类为2008年之前注册的96项试验，并在2008年至2017年期间登记的审判。我们发现，在过去的十年中，转移性和先进的肉瘤试验主要是II-III研究（P？= 0.048 ），更可能是≥2臂（分别为17.7％，分别与35.3％; p？= 0.007），并且更有可能随机使用（13.5％Vs 30.4％; p？= 0.002）并双盲（2.1％vs 9.4％; p？=？0.024）分配比2008年之前注册的试验。此外，在过去的10年期间，转移性肉瘤试验更有可能在亚洲进行。涉及靶治疗和免疫疗法的治疗更常见（71.8％vs 37.5％; p？<0.001）比前几年。我们的数据显示了肉瘤景观中的挑衅性变化，并表明临床试验与靶治疗和免疫疗法的发生率正在增加。这些调查结果强调了绝望的新策略，包括靶治疗和免疫疗法，以改善先进肉瘤患者的结果。

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