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)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
|---|---|
| Enthalten in: |
BMJ open - 14(2024), 3 vom: 08. März, Seite e075642 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kong, Yuehong [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
IMMUNOLOGY |
|---|
| Anmerkungen: |
Date Completed 11.03.2024 Date Revised 14.03.2024 published: Electronic ClinicalTrials.gov: NCT05790447 Citation Status MEDLINE |
|---|
| doi: |
10.1136/bmjopen-2023-075642 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM369485475 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM369485475 | ||
| 003 | DE-627 | ||
| 005 | 20240314235417.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240309s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1136/bmjopen-2023-075642 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1329.xml |
| 035 | |a (DE-627)NLM369485475 | ||
| 035 | |a (NLM)38458816 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Kong, Yuehong |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours |b protocol for the open-label, prospective, multicentre study (PRaG5.0 study) |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 11.03.2024 | ||
| 500 | |a Date Revised 14.03.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05790447 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05790447 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a IMMUNOLOGY | |
| 650 | 4 | |a Protocols & guidelines | |
| 650 | 4 | |a RADIOTHERAPY | |
| 650 | 7 | |a Thymalfasin |2 NLM | |
| 650 | 7 | |a W0B22ISQ1C |2 NLM | |
| 650 | 7 | |a Immune Checkpoint Inhibitors |2 NLM | |
| 650 | 7 | |a Programmed Cell Death 1 Receptor |2 NLM | |
| 700 | 1 | |a Chen, Rongzheng |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Meiling |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Junjun |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Guangqiang |e verfasserin |4 aut | |
| 700 | 1 | |a Hong, Zhihui |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Dai, Xiaoxiao |e verfasserin |4 aut | |
| 700 | 1 | |a Ma, Yifu |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Xiangrong |e verfasserin |4 aut | |
| 700 | 1 | |a Peng, Yong |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Chenyang |e verfasserin |4 aut | |
| 700 | 1 | |a Xing, Pengfei |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Liyuan |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMJ open |d 2011 |g 14(2024), 3 vom: 08. März, Seite e075642 |w (DE-627)NLM215724372 |x 2044-6055 |7 nnns |
| 773 | 1 | 8 | |g volume:14 |g year:2024 |g number:3 |g day:08 |g month:03 |g pages:e075642 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1136/bmjopen-2023-075642 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 14 |j 2024 |e 3 |b 08 |c 03 |h e075642 | ||