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A phase I clinical trial of sonodynamic therapy combined with temozolomide in the treatment of recurrent glioblastoma

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Abstract

Purpose

The prognosis of recurrent glioblastoma (rGBM) is poor, and there is currently no effective treatment strategy. Sonodynamic therapy (SDT) is a new method for cancer treatment that uses a combination of low-frequency ultrasound and sonosensitisers to produce antitumor effects, which have shown good therapeutic effects in preclinical studies. Therefore, we initiated an open, prospective pilot study to evaluate the safety, tolerability, and efficacy of SDT for the treatment of rGBM.

Methods

Nine patients with rGBM were enrolled who had received multiple treatments, but the nidus continued to progress without additional standard treatments. After MRI localisation, porphyrin drugs were injected, and intermittent low-frequency ultrasound therapy was performed for five days.

Results

None of the nine patients in this clinical trial showed any clinical, neurological, haematological, or skin-targeted adverse effects associated with SDT. After the completion of the trial, one patient maintained stable disease, and eight patients experienced disease progression. Among the eight with progressive disease, the median progression-free survival time was 84 days. Four patients died, and the median overall survival duration after recurrence was 202.5 days.

Conclusion

The number of patients in this study was small; therefore, a long-term survival benefit was not demonstrated. However, this study suggests that SDT has potential as a treatment for rGBM and warrants further exploration. Trial information: Chinese Clinical Trial Registry (http://www.chictr.org.cn/): ChiCTR2200065992. November 2, 2022, retrospectively registered.

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Data and material sharing Statement

The date that supports the findings of this study is openly available in ResMan, at http://www.medresman.org.cn.

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Acknowledgements

We thank the patients and their families for participating in this study and for their efforts to cooperate with us in the follow-up.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Authors and Affiliations

  1. Department of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Erqi District, Zhengzhou, 450052, Henan, China

    Boya Zha, Junping Yang, Qianqian Dang, Peihong Li, Shuling Shi, Jingjing Wu, Haiyang Cui, Linkuan Huangfu, Yuxin Li, Daoke Yang & Yingjuan Zheng

  2. Institute of Radiotherapy and Critical Care Oncology, Zhengzhou University, Zhengzhou, 450000, Henan, China

    Daoke Yang & Yingjuan Zheng

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  1. Boya Zha
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Contributions

All authors contributed to the article and approved the submitted version. Boya Zha conducted data collection, analysis and article writing; Junping Yang, Qianqian Dang, Boya Zha and Yingjuan Zheng worked out the treatment plans of every patient; Peihong Li, Shuling Shi, Haiyang Cui and Linkuan Huangfu collected the data; Boya Zha, Yuxin Li, Jingjing Wang and Daoke Yang participated in the imaging evaluation.

Corresponding author

Correspondence to Yingjuan Zheng.

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The authors have no relevant financial or non-financial interests to disclose.

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The authors affirm that human research participants provided informed consent for publication of the images in Figure(s) 1 A, 1B and 2.

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Informed consent was obtained from all individual participants included in the study.

Ethics

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the First Affiliated Hospital of Zhengzhou University, China (Ethics number: L/G2022-K001-003). Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn/): ChiCTR2200065992. November 2, 2022, retrospectively registered.

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Zha, B., Yang, J., Dang, Q. et al. A phase I clinical trial of sonodynamic therapy combined with temozolomide in the treatment of recurrent glioblastoma. J Neurooncol 162, 317–326 (2023). https://doi.org/10.1007/s11060-023-04292-9

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