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胰腺癌临床试验的综合分析:未来会有什么进展?

A comprehensive analysis of clinical trials in pancreatic cancer: what is coming down the pike?

作者信息

Katayama Erryk S, Hue Jonathan J, Bajor David L, Ocuin Lee M, Ammori John B, Hardacre Jeffrey M, Winter Jordan M

机构信息

Department of Surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

Department of Surgery, University Hospitals Seidman Cancer Center and Case Comprehensive Cancer Center, Cleveland, Ohio, USA.

出版信息

Oncotarget. 2020 Sep 22;11(38):3489-3501. doi: 10.18632/oncotarget.27727.

Abstract

OBJECTIVE

Pancreatic cancer is the most aggressive common cancer and is desperately in need of novel therapies. Unlike many other common cancers, there have been no new paradigm-changing therapies in the past 40 years beyond multi-agent chemotherapy. In this study, we perform the first comprehensive analysis of the current clinical trial landscape in pancreatic cancer to better understand the pipeline of new therapies.

MATERIALS AND METHODS

We queried https://clinicaltrials.gov/ for registered pancreatic cancer clinical trials. Studies were curated and categorized according to phase of study, clinical stage of the study population, type of the intervention under investigation, and biologic mechanism targeted by the therapy under study.

RESULTS

As of May 18, 2019, there were 430 total active therapeutic interventional trials testing 590 interventions. The vast minority of trials ( = 37, 8.6%) are in phase III testing. 189 (31%) interventions are immunotherapies, 69 (11%) target cell signaling pathways, 154 (26%) target cell cycle or DNA biology, and 35 (6%) target metabolic pathways. Of the late phase trials, only 14 are currently testing novel interventions. Rather, 23 phase III trials examine new ways to deliver existing FDA-approved drugs, procedures, or pain management.

CONCLUSIONS

A large number of novel therapeutic strategies are currently under investigation. They include a broad range of therapies targeting diverse biologic processes. However, only a small number of novel therapies are in late-stage testing, suggesting that future progress is likely several years away, and dependent on the success of early-stage trials.

摘要

目的

胰腺癌是侵袭性最强的常见癌症,迫切需要新的治疗方法。与许多其他常见癌症不同,在过去40年里,除了多药化疗外,没有出现改变范式的新疗法。在本研究中,我们对当前胰腺癌临床试验情况进行了首次全面分析,以更好地了解新疗法的研发进程。

材料与方法

我们在https://clinicaltrials.gov/上查询已注册的胰腺癌临床试验。根据研究阶段、研究人群的临床分期、所研究的干预类型以及所研究疗法靶向的生物学机制对研究进行整理和分类。

结果

截至2019年5月18日,共有430项正在进行的活性治疗性干预试验,测试590种干预措施。极少数试验(n = 37,8.6%)处于III期试验阶段。189种(31%)干预措施是免疫疗法,69种(11%)靶向细胞信号通路,154种(26%)靶向细胞周期或DNA生物学,35种(6%)靶向代谢途径。在晚期试验中,目前只有14项在测试新的干预措施。相反,有23项III期试验在研究递送现有FDA批准药物、程序或疼痛管理的新方法。

结论

目前正在研究大量新的治疗策略。它们包括针对多种生物学过程的广泛疗法。然而,只有少数新疗法处于后期测试阶段,这表明未来的进展可能还需要数年时间,并且取决于早期试验的成功。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba74/7517959/5eab5bc7078d/oncotarget-11-3489-g001.jpg

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