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Clinical Trial Protocol

Design of a single-center, phase II trial to explore the efficacy and safety of ‘R-ISV-RO’ treatment in advanced tumors

    Limei Min

    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

    ,
    Xiaolu Wang

    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

    ,
    Anni Chen

    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

    ,
    Yingling Zhou

    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

    ,
    Yuchen Ge

    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

    ,
    Juanjuan Dai

    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

    ,
    Xiaofeng Chang

    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

    ,
    Wu Sun

    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

    ,
    Qin Liu

    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

    ,
    Xia Zhou

    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

    ,
    Manman Tian

    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

    ,
    Wentao Kong

    Department of Ultrasound Diagnosis, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, No. 321 Zhongshan Road, Gulou District, Nanjing City, Jiangsu Province, 210008, China

    ,
    Junmeng Zhu

    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

    ,
    Jie Shen

    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

    ,
    Baorui Liu

    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

    &
    Rutian Li

    *Author for correspondence:

    E-mail Address: rutianli@nju.edu.cn

    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

    Published Online:https://doi.org/10.2217/fon-2023-0962

    Background: 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’ insitu strategy plus anti-PD-1 monoclonal antibody in advanced tumors. Methods: 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. Discussion/Conclusion: The efficacy and safety of the novel strategy will be further validated through this clinical trial.

    Clinical trial registration: ChiCTR2100053870 (www.chictr.org.cn/)

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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