Division of Surgery and Cancer, Hammersmith Hospital, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Department of Oncology, Hammersmith Hospital, Imperial College NHS Healthcare Trust, Du Cane Road, London, W12 0HS, UK.
BMC Cancer. 2022 Jul 20;22(1):800. doi: 10.1186/s12885-022-09859-9.
Neuroendocrine neoplasias (NENs) are a rare type of malignancy that arise from the cells of the neuroendocrine system. Most patients present with advanced, unresectable disease, typically with metastases to the liver. The presence of liver metastases dictates prognosis and there has been a number of studies investigating therapies that reduce the burden of liver disease. Selective Internal Radiation Therapy (SIRT) allows the delivery of targeted high dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Here, we describe the design and rationale of ArtTisaN, a phase II study to assess efficacy and tolerability of SIRT using TheraSpheres for the management of liver metastases secondary to NENs.
Twenty-four eligible participants will be recruited to receive SIRT with TheraSpheres. The primary objective is to determine the objective response rate to treatment, defined as the rate of best overall response in the treated liver volume. In addition, total hepatic response and overall response will be assessed according to RECIST 1.1. The second co-primary objective is to determine the incidence of adverse and serious adverse device events. The secondary objectives are progression free survival, overall survival and quality of life. Additional exploratory objectives include investigation of circulating biomarkers of response and identification of a radiomic signature of response.
This trial will provide prospective evidence on the efficacy of SIRT using TheraSpheres for the management of liver metastases.
NCT04362436 .
神经内分泌肿瘤（NENs）是一种罕见的恶性肿瘤，起源于神经内分泌系统的细胞。大多数患者表现为晚期、不可切除的疾病，通常伴有肝转移。肝转移的存在决定了预后，已经有许多研究探讨了减少肝病负担的治疗方法。选择性内放射治疗（SIRT）允许将高剂量的靶向辐射直接输送到肿瘤，同时相对保护周围的肝组织。在这里，我们描述了 ArtTisaN 的设计和原理，这是一项评估 SIRT 使用 TheraSpheres 治疗 NENs 继发肝转移的疗效和耐受性的 II 期研究。
将招募 24 名符合条件的参与者接受 SIRT 联合 TheraSpheres 治疗。主要目的是确定治疗的客观缓解率，定义为治疗肝体积内最佳总体缓解率。此外，根据 RECIST 1.1 评估总肝反应和总体反应。第二个主要次要终点是确定不良和严重不良设备事件的发生率。次要目标是无进展生存期、总生存期和生活质量。其他探索性目标包括对反应的循环生物标志物的研究和对反应的放射组学特征的鉴定。
这项试验将为使用 TheraSpheres 进行 SIRT 治疗肝转移提供前瞻性疗效证据。
NCT04362436 。
