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
Abstract 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...
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Springer
2025-02-01
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| Series: | Cancer Immunology, Immunotherapy |
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| Online Access: | https://doi.org/10.1007/s00262-024-03934-9 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jiamin Yu |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-3eb8b44fd17d4e8f930003c6052da7f4 |
| institution | Kabale University |
| issn | 1432-0851 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Springer |
| record_format | Article |
| series | Cancer Immunology, Immunotherapy |
| spelling | doaj-art-3eb8b44fd17d4e8f930003c6052da7f42025-02-09T12:39:10ZengSpringerCancer Immunology, Immunotherapy1432-08512025-02-0174311010.1007/s00262-024-03934-9Hypofractionated 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 trialJiamin Yu0Li Yin1Wenjie Guo2Qiang Wang3Juying Liu4Lansheng Zhang5Hongxun Ye6Jianhong Xia7Youyou Xia8Jianfeng Wu9Wanwei Wang10Yanguang Yang11Dan Zong12Xia He13Lijun Wang14Hong Jiang15Department of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, Xuzhou Cancer HospitalDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, The Second Affiliated Hospital of Xuzhou Medical UniversityDepartment of Radiation Oncology, Taixing People’s Hospital Affiliated With Medical College of Yangzhou UniversityDepartment of Radiation Oncology, Huai’an Second People’s Hospital, The Affiliated Huai’an Hospital of Xuzhou Medical UniversityDepartment of Radiation Oncology, The First People’s Hospital of LianyungangDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, The Affiliated Huai’an No.1 People’s Hospital of Nanjing Medical UniversityDepartment of Radiation Oncology, Nantong Cancer HospitalDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, Affiliated Cancer Hospital of Nanjing Medical University, &Jiangsu Cancer Hospital & Jiangsu Institute of Cancer ResearchDepartment of Radiation Oncology, The People’s Hospital of Jiawang District of Xuzhou CityAbstract 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.https://doi.org/10.1007/s00262-024-03934-9Hypofractionated radiotherapyImmunotherapyPD-1 inhibitorGranulocyte macrophage-colony stimulating factorThymosin-α1Abscopal effect |
| spellingShingle | 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 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 Cancer Immunology, Immunotherapy Hypofractionated radiotherapy Immunotherapy PD-1 inhibitor Granulocyte macrophage-colony stimulating factor Thymosin-α1 Abscopal effect |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Hypofractionated radiotherapy Immunotherapy PD-1 inhibitor Granulocyte macrophage-colony stimulating factor Thymosin-α1 Abscopal effect |
| url | https://doi.org/10.1007/s00262-024-03934-9 |
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