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中文摘要
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介入肿瘤学(IO)正在成为与癌症治疗并列的第四支柱 内科、放射和外科肿瘤学。介入性肿瘤学家提供微创 图像引导疗法治疗癌症,没有化疗的毒副作用和毁容, 放射治疗或手术。新的临床试验设计和协作对于确定 以及IO疗法何时应整合到多学科护理计划中以实现最佳 癌症患者的结局。实现这一目标的障碍很多。试验设计必须满足 阶段性和可重复治疗,这使事件发生时间分析变得复杂。这是一个稀缺的 介入肿瘤学临床研究人员,他们需要与其他 肿瘤学学科为临床试验开发新的概念和方案。美国国家情报局 协作群体层次结构是医学肿瘤学的研究领域。外科和介入性 概念难以跨越审查过程的多个层面,这是 招聘和留住青年调查员。只有不到5%的>100 NCTN试验在 申请人的癌症中心涉及不止一个癌症专科,这是一个明显的迹象 跨学科临床研究的不足。进行跨学科的试验充满了 当治疗医生在不同的地方执业时,后勤和管理方面的挑战 部门,这在历史上是试验失败的主要决定因素。 IO高级临床研究专家的角色是在以下位置解决每个障碍 机构和NCTN层面。这从教授临床试验设计和实施开始 来自所有癌症学科的年轻研究人员的新干部。跨学科协作可以 然后在NCTN机构内部和跨NCTN机构创建,以生成新的试验概念 系统疗法和影像引导疗法的交叉,以创造新的治疗协同效应。 成熟的研究领域包括通过靶向HIF激活来增强缺血, 自噬和自由基的产生;选择性内辐射的增强 放射增敏剂.增强热基治疗以提高消融范围.消融 和作为免疫刺激剂的栓塞术以加强免疫检查点抑制;图像引导 CAR-T细胞进入实体瘤;直接注射和淋巴内给药 以疫苗为基础的制剂;以及用于输送治疗剂的纳米结构。这些小说 概念需要通过错综复杂的NCTN过程和新平台进行指导 为执行跨部门临床试验而开发。
英文摘要
Interventional Oncology (IO) is emerging as the fourth pillar of cancer care alongside medical, radiation, and surgical oncology. Interventional oncologists provide minimally invasive image-guided therapies to treat cancers without the toxicities and disfigurement of chemotherapy, radiation or surgery. New clinical trial designs and collaborations are essential to determine how and when IO therapies should be integrated into multidisciplinary care plans to achieve optimal outcomes for cancer patients. Obstacles to this are many. Trial designs must accommodate staged and repeatable therapies, which complicates time-to-event analysis. There is a dearth of interventional oncology clinical investigators, who are needed to build collaborations with other oncologic disciplines to develop new concepts and protocols for clinical trials. The NCI cooperative group hierarchy is the domain of medical oncology. Surgical and interventional concepts struggle to hurdle the many layers of the review process, which is a barrier to the recruitment and retention of young investigators. Less than 5% of the >100 NCTN trials open at the applicant’s cancer center involve more than one cancer specialty, a stark indicator of the deficit in interdisciplinary clinical research. Conducting interdisciplinary trials is fraught with logistical and administrative challenges when the treating physicians practice in different departments, which historically is a major determinant of trial failure. The role of a senior IO clinical research specialist is to address each of these obstacles at the institutional and NCTN level. This starts with teaching clinical trial design and execution to a new cadre of young investigators from all cancer disciplines. Interdisciplinary collaborations can then be created within and across NCTN institutions to generate new trial concepts investigating the intersection of systemic and image-guided therapies to create new therapeutic synergies. Areas ripe for investigation include potentiation of ischemia by targeting HIF activation, autophagy, and free radical generation; potentiation of selective internal radiation with radiosensitizers; potentiation of thermal-based therapies to improve ablation margins; ablation and embolization as immunostimulants to potentiate immune checkpoint inhibition; image-guided delivery of CAR-T cells into solid tumors; direct injection and intralymphatic administration of vaccine-based agents; and nanoconstructs for delivery of therapeutic agents. These novel concepts need to be guided through the labyrinthian NCTN process, and new platforms developed for execution of interdepartmental clinical trials.
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