Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)
Introduction The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients wit...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e075642.full |
| _version_ | 1797267985337942016 |
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| author | Yong Peng Hong Zhang Junjun Zhang Liyuan Zhang Pengfei Xing Yuehong Kong Rongzheng Chen Meiling Xu Guangqiang Chen Zhihui Hong Xiaoxiao Dai Yifu Ma Xiangrong Zhao Chenyang Zhang |
| author_facet | Yong Peng Hong Zhang Junjun Zhang Liyuan Zhang Pengfei Xing Yuehong Kong Rongzheng Chen Meiling Xu Guangqiang Chen Zhihui Hong Xiaoxiao Dai Yifu Ma Xiangrong Zhao Chenyang Zhang |
| author_sort | Yong Peng |
| collection | DOAJ |
| description | Introduction The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.Objective The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.Methods and analysis The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.Ethics and dissemination The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.Trial registration number NCT05790447. |
| first_indexed | 2024-04-25T01:25:17Z |
| format | Article |
| id | doaj.art-ef1743c3427446bca18e3314d58222c7 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-25T01:25:17Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-ef1743c3427446bca18e3314d58222c72024-03-09T01:55:09ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-075642Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)Yong Peng0Hong Zhang1Junjun Zhang2Liyuan Zhang3Pengfei Xing4Yuehong Kong5Rongzheng Chen6Meiling Xu7Guangqiang Chen8Zhihui Hong9Xiaoxiao Dai10Yifu Ma11Xiangrong Zhao12Chenyang Zhang131 Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China1 Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA17 Department of Ophthalmology, Sichuan University West China Hospital, Chengdu, Sichuan, China1 State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaNeurovascular Center, Naval Medical University Changhai Hospital, Shanghai, ChinaCenter for Cancer Diagnosis and Treatment, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaCenter for Cancer Diagnosis and Treatment, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaDepartment of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaDepartment of Radiology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaDepartment of Nuclear Medicine, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaDepartment of Pathology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaCenter for Cancer Diagnosis and Treatment, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaCenter for Cancer Diagnosis and Treatment, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaCenter for Cancer Diagnosis and Treatment, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaIntroduction The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.Objective The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.Methods and analysis The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.Ethics and dissemination The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.Trial registration number NCT05790447.https://bmjopen.bmj.com/content/14/3/e075642.full |
| spellingShingle | Yong Peng Hong Zhang Junjun Zhang Liyuan Zhang Pengfei Xing Yuehong Kong Rongzheng Chen Meiling Xu Guangqiang Chen Zhihui Hong Xiaoxiao Dai Yifu Ma Xiangrong Zhao Chenyang Zhang Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study) BMJ Open |
| title | Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study) |
| title_full | Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study) |
| title_fullStr | Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study) |
| title_full_unstemmed | Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study) |
| title_short | Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study) |
| title_sort | evaluation of the efficacy and safety of a precise thymalfasin regulated prag regimen for advanced refractory solid tumours protocol for the open label prospective multicentre study prag5 0 study |
| url | https://bmjopen.bmj.com/content/14/3/e075642.full |
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