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Purpose <p>This multicenter Phase II clinical study assessed the efficacy and safety of hypofractionated radiotherapy (HFRT) in combination with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor (GM-CSF), and thymosin-α1 in patients with heavily treated metastatic solid tumors.</p> Methods <p>Patients were enrolled between September 2022 and May 2024. HFRT was administered to targeted tumors, and GM-CSF was administered for 14&#xa0;days from day 1 of radiotherapy. Thymosin-α1 was injected concurrently twice weekly until disease progression. Immunotherapy with camrelizumab was started following HFRT and repeated every 3&#xa0;weeks. GM-CSF was administered daily for 7&#xa0;days before each cycle of immunotherapy.</p> Results <p>By June 15, 2024, there were 37 study participants. The median follow-up duration was 5.97&#xa0;months (range 0.40–20.9). Median progression-free survival was 3.5&#xa0;months (95% confidence interval 2.73–4.23) in the intention-to-treat population. The objective response rate was 23.08%, and the disease control rate was 65.38%. Overall survival data are not yet mature. Abscopal effects were observed in 6 patients (23.08%); four of whom achieved a partial response. Patients who achieved a partial response were significantly more likely to have an abscopal effect(<i> P</i> = 0.025). The group with a lower baseline neutrophil–lymphocyte ratio had a significantly lower risks of distant metastasis and death(<i> P</i> = 0.024). Seventeen adverse reactions were reported, including six grade 3 or 4 adverse events. There were no grade 5 adverse events.</p> Conclusion <p>In conclusion, the trends in efficacy observed in our study are promising; however, well-designed protocols are essential to validate these findings.</p>

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Hypofractionated radiotherapy combined with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor, and thymosin-α1 in advanced metastatic solid tumors: a multicenter Phase II clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月4日

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  • Jiamin Yu,
  • Li Yin,
  • Wenjie Guo,
  • Qiang Wang,
  • Juying Liu,
  • Lansheng Zhang,
  • Hongxun Ye,
  • Jianhong Xia,
  • Youyou Xia,
  • Jianfeng Wu,
  • Wanwei Wang,
  • Yanguang Yang,
  • Dan Zong,
  • Xia He,
  • Lijun Wang,
  • Hong Jiang

摘要

Purpose

This multicenter Phase II clinical study assessed the efficacy and safety of hypofractionated radiotherapy (HFRT) in combination with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor (GM-CSF), and thymosin-α1 in patients with heavily treated metastatic solid tumors.

Methods

Patients were enrolled between September 2022 and May 2024. HFRT was administered to targeted tumors, and GM-CSF was administered for 14 days from day 1 of radiotherapy. Thymosin-α1 was injected concurrently twice weekly until disease progression. Immunotherapy with camrelizumab was started following HFRT and repeated every 3 weeks. GM-CSF was administered daily for 7 days before each cycle of immunotherapy.

Results

By June 15, 2024, there were 37 study participants. The median follow-up duration was 5.97 months (range 0.40–20.9). Median progression-free survival was 3.5 months (95% confidence interval 2.73–4.23) in the intention-to-treat population. The objective response rate was 23.08%, and the disease control rate was 65.38%. Overall survival data are not yet mature. Abscopal effects were observed in 6 patients (23.08%); four of whom achieved a partial response. Patients who achieved a partial response were significantly more likely to have an abscopal effect( P = 0.025). The group with a lower baseline neutrophil–lymphocyte ratio had a significantly lower risks of distant metastasis and death( P = 0.024). Seventeen adverse reactions were reported, including six grade 3 or 4 adverse events. There were no grade 5 adverse events.

Conclusion

In conclusion, the trends in efficacy observed in our study are promising; however, well-designed protocols are essential to validate these findings.