A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028
BackgroundNeoantigen-based vaccines show promising therapeutic potential in solid tumors such as melanoma, GBM, NSCLC, and CRC. However, clinical responses remain suboptimal in stage IV patients, due to ineffective T-cell function and high tumor burdens. To overcome these limitations, our study inve...
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Frontiers Media S.A.
2025-08-01
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| author | Yan Zhang Yan Zhang Yan Zhang Ye-Fan Hu Ye-Fan Hu Lingyu Ma Lingyu Ma Yifei Wu Yifei Wu Dandan Chao Dandan Chao Xian Chen Xian Chen Zhiyuan Xu Zhiyuan Xu Xiaoping Su Xiaoping Su Wei Dai Wei Dai Wei Dai Jiandong Huang Jiandong Huang Jiandong Huang Jiandong Huang Pingfu Fu Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong |
| author_facet | Yan Zhang Yan Zhang Yan Zhang Ye-Fan Hu Ye-Fan Hu Lingyu Ma Lingyu Ma Yifei Wu Yifei Wu Dandan Chao Dandan Chao Xian Chen Xian Chen Zhiyuan Xu Zhiyuan Xu Xiaoping Su Xiaoping Su Wei Dai Wei Dai Wei Dai Jiandong Huang Jiandong Huang Jiandong Huang Jiandong Huang Pingfu Fu Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong |
| author_sort | Yan Zhang |
| collection | DOAJ |
| description | BackgroundNeoantigen-based vaccines show promising therapeutic potential in solid tumors such as melanoma, GBM, NSCLC, and CRC. However, clinical responses remain suboptimal in stage IV patients, due to ineffective T-cell function and high tumor burdens. To overcome these limitations, our study investigates a combination strategy using neoantigen peptide vaccines and precision critical lesion radiotherapy (CLERT), which delivers immunomodulatory doses to key tumor regions synergistically enhance immune activation and inhibit progression in multifocal stage IV patients.Materials/MethodsThis is an open-label, multicenter phase II randomized study. The main objective is to evaluate the anti-tumor efficacy of personalized tumor neoantigen peptide vaccines and assess how different radiation doses synergize with vaccination in treating patients with advanced malignant tumors who have progressed after systemic therapy. Patients are stratified by cancer type and randomized 1:1 to receive either placebo with conventional treatment (including high and low dose radiotherapy) or a personalized neoantigen peptide vaccine alongside conventional treatment (including high and low dose radiotherapy). A one-way crossover design is implemented, permitting patients in the placebo arm to transition to the experimental arm upon progression. Clinical outcomes including progression-free survival and objective response rate are assessed both before and after crossover. Key inclusion criteria are as follows: 1) Patients with advanced or recurrent cancers detected by pathology and imaging, who failed first-line treatments; 2) Patients with projected survival ≥3 months and an ECOG score of 0-2; and 3) Patients with at least one predicted high-quality tumor neoantigen.ConclusionThis trial introduces an innovative combination strategy of precision radiotherapy and neoantigen vaccine. A notable feature of this study is the incorporation of a randomized control and intra-group crossover design, which is rarely utilized in neoantigen trials. The study is designed to provide critical insight into radiation-immune synergy and the clinical benefit of personalized immunization. Additionally, a basket-trial framework is employed, leveraging shared neoantigens across cancer types to improve efficiency and generalizability. This approach may reduce preparation time and cost, facilitating broader implementation of neoantigen-based immunotherapies. Altogether, this trial design represents a significant step toward translational application of tumor neoantigen vaccines and provides a platform for future combinational immunotherapy strategies.Trial registrationhttps://clinicaltrials.gov/study/NCT06314087, identifier: NCT06314087; www.chictr.org.cn, identifier: ChiCTR2300078055. Global Collaborative Oncology Group (GCOG) identifier: GCOG0028. |
| format | Article |
| id | doaj-art-096ce1eb33fe481fbd87c143f4229cf0 |
| institution | Kabale University |
| issn | 1664-3224 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj-art-096ce1eb33fe481fbd87c143f4229cf02025-08-21T05:27:11ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-08-011610.3389/fimmu.2025.15380321538032A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028Yan Zhang0Yan Zhang1Yan Zhang2Ye-Fan Hu3Ye-Fan Hu4Lingyu Ma5Lingyu Ma6Yifei Wu7Yifei Wu8Dandan Chao9Dandan Chao10Xian Chen11Xian Chen12Zhiyuan Xu13Zhiyuan Xu14Xiaoping Su15Xiaoping Su16Wei Dai17Wei Dai18Wei Dai19Jiandong Huang20Jiandong Huang21Jiandong Huang22Jiandong Huang23Pingfu Fu24Feng-Ming (Spring) Kong25Feng-Ming (Spring) Kong26Feng-Ming (Spring) Kong27Feng-Ming (Spring) Kong28Department of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaThe Hong Kong University Shenzhen Hospital Translational Medicine Centre, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaSchool of Biomedical Sciences, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, ChinaCancer Research Centre, BayVax Biotech Limited, Hong Kong, Hong Kong SAR, ChinaDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaSchool of Basic Medicine, Wenzhou Medical University, Wenzhou, ChinaDepartment of Gastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, ChinaDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Centre of Cancer Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong Kong SAR, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaSchool of Biomedical Sciences, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, ChinaChinese Academy of Sciences (CAS) Key Laboratory of Quantitative Engineering Biology, Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, China0Guangdong-Hong Kong Joint Laboratory for RNA Medicine, Sun Yat-Sen University, Guangzhou, China1Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH, United StatesDepartment of Clinical Oncology, University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaDepartment of Clinical Oncology, Shenzhen Key Laboratory for Cancer Metastasis and Personalized Therapy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, ChinaThe Hong Kong University Shenzhen Hospital Translational Medicine Centre, University of Hong Kong-Shenzhen Hospital, Shenzhen, China2Department of Clinical Oncology, Hong Kong University Li Ka Shing Medical School, Hong Kong, Hong Kong SAR, ChinaBackgroundNeoantigen-based vaccines show promising therapeutic potential in solid tumors such as melanoma, GBM, NSCLC, and CRC. However, clinical responses remain suboptimal in stage IV patients, due to ineffective T-cell function and high tumor burdens. To overcome these limitations, our study investigates a combination strategy using neoantigen peptide vaccines and precision critical lesion radiotherapy (CLERT), which delivers immunomodulatory doses to key tumor regions synergistically enhance immune activation and inhibit progression in multifocal stage IV patients.Materials/MethodsThis is an open-label, multicenter phase II randomized study. The main objective is to evaluate the anti-tumor efficacy of personalized tumor neoantigen peptide vaccines and assess how different radiation doses synergize with vaccination in treating patients with advanced malignant tumors who have progressed after systemic therapy. Patients are stratified by cancer type and randomized 1:1 to receive either placebo with conventional treatment (including high and low dose radiotherapy) or a personalized neoantigen peptide vaccine alongside conventional treatment (including high and low dose radiotherapy). A one-way crossover design is implemented, permitting patients in the placebo arm to transition to the experimental arm upon progression. Clinical outcomes including progression-free survival and objective response rate are assessed both before and after crossover. Key inclusion criteria are as follows: 1) Patients with advanced or recurrent cancers detected by pathology and imaging, who failed first-line treatments; 2) Patients with projected survival ≥3 months and an ECOG score of 0-2; and 3) Patients with at least one predicted high-quality tumor neoantigen.ConclusionThis trial introduces an innovative combination strategy of precision radiotherapy and neoantigen vaccine. A notable feature of this study is the incorporation of a randomized control and intra-group crossover design, which is rarely utilized in neoantigen trials. The study is designed to provide critical insight into radiation-immune synergy and the clinical benefit of personalized immunization. Additionally, a basket-trial framework is employed, leveraging shared neoantigens across cancer types to improve efficiency and generalizability. This approach may reduce preparation time and cost, facilitating broader implementation of neoantigen-based immunotherapies. Altogether, this trial design represents a significant step toward translational application of tumor neoantigen vaccines and provides a platform for future combinational immunotherapy strategies.Trial registrationhttps://clinicaltrials.gov/study/NCT06314087, identifier: NCT06314087; www.chictr.org.cn, identifier: ChiCTR2300078055. Global Collaborative Oncology Group (GCOG) identifier: GCOG0028.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1538032/fullneoantigen vaccineradiotherapyimmunotherapyT cell responselow-dose radiationhigh-dose radiation |
| spellingShingle | Yan Zhang Yan Zhang Yan Zhang Ye-Fan Hu Ye-Fan Hu Lingyu Ma Lingyu Ma Yifei Wu Yifei Wu Dandan Chao Dandan Chao Xian Chen Xian Chen Zhiyuan Xu Zhiyuan Xu Xiaoping Su Xiaoping Su Wei Dai Wei Dai Wei Dai Jiandong Huang Jiandong Huang Jiandong Huang Jiandong Huang Pingfu Fu Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong Feng-Ming (Spring) Kong A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028 Frontiers in Immunology neoantigen vaccine radiotherapy immunotherapy T cell response low-dose radiation high-dose radiation |
| title | A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028 |
| title_full | A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028 |
| title_fullStr | A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028 |
| title_full_unstemmed | A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028 |
| title_short | A phase II randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy (iNATURE) in advanced solid tumors-GCOG0028 |
| title_sort | phase ii randomized trial of individualized neoantigen peptide vaccine combined with unusual radiotherapy inature in advanced solid tumors gcog0028 |
| topic | neoantigen vaccine radiotherapy immunotherapy T cell response low-dose radiation high-dose radiation |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1538032/full |
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