一项探索 'R-ISV-RO' 治疗晚期肿瘤的疗效和安全性的单中心、二期临床试验设计。
Design of a single-center, phase II trial to explore the efficacy and safety of 'R-ISV-RO' treatment in advanced tumors.
机构信息
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, No. 321 Zhongshan Road, Gulou District, Nanjing City, Jiangsu Province, 210008, China.
The Comprehensive Cancer Centre of Nanjing Drum Tower Hospital, Clinical College of Traditional Chinese & Western Medicine, Nanjing University of Chinese Medicine, No. 321 Zhongshan Road, Gulou District, Nanjing City, Jiangsu Province, 210008, China.
出版信息
Future Oncol. 2024;20(17):1139-1149. doi: 10.2217/fon-2023-0962. Epub 2024 Mar 6.
The authors' preclinical study has confirmed that RO adjuvant (composed of TLR 7 agonists [imiquimod/R837] and OX40 agonists) injected into local lesions induces the regression of both primary tumor and distant metastasis. The authors propose to realize local control and exert abscopal effect through an 'R-ISV-RO' strategy plus anti-PD-1 monoclonal antibody in advanced tumors. This study is a single-center, exploratory, phase II trial to evaluate the efficacy and safety of R-ISV-RO plus anti-PD-1 monoclonal antibody in advanced tumors. 30 patients with one or more measurable extracerebral lesions that are accessible for radiation or injection will be enrolled. The primary endpoint is the objective response rate of target lesions. The efficacy and safety of the novel strategy will be further validated through this clinical trial. ChiCTR2100053870 (www.chictr.org.cn/).
作者的临床前研究证实，RO 佐剂（由 TLR7 激动剂[咪喹莫特/R837]和 OX40 激动剂组成）注射到局部病变部位可诱导原发性肿瘤和远处转移的消退。作者提出通过“R-ISV-RO”策略加抗 PD-1 单克隆抗体在晚期肿瘤中实现局部控制和发挥远隔效应。这项研究是一项单中心、探索性、Ⅱ期临床试验，旨在评估 R-ISV-RO 联合抗 PD-1 单克隆抗体在晚期肿瘤中的疗效和安全性。将招募 30 名有一个或多个可测量的脑外病变的患者，这些病变可通过放疗或注射来治疗。主要终点是靶病变的客观缓解率。通过这项临床试验将进一步验证该新策略的疗效和安全性。ChiCTR2100053870（www.chictr.org.cn/）。
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