Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study)

Current evidence from evidence-based medicine is limited regarding the efficacy and safety of immunotherapy in elderly patients aged 75 years and older with malignant solid tumors. PRaG therapy, which combines PD-1/PD-L1 inhibitors, radiotherapy, and granulocyte-macrophage colony-stimulating factor...

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Veröffentlicht in:Technology in cancer research & treatment Jg. 24; S. 15330338251400412
Hauptverfasser: Zhao, Xiangrong, Yang, MengMeng, Zhang, Junjun, Kong, Yuehong, Xu, Meiling, Chen, Rongzheng, Yin, Qian, Wang, Sumeng, Chen, Guangqiang, Xing, Pengfei, Zhang, Liyuan
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States SAGE Publishing 01.01.2025
Schlagworte:
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Clinical Trials, Phase II as Topic
Female
Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage
Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects
Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use
Humans
Immune Checkpoint Inhibitors - administration & dosage
Immune Checkpoint Inhibitors - adverse effects
Immune Checkpoint Inhibitors - therapeutic use
Male
Multicenter Studies as Topic
Neoplasm Staging
Neoplasms - drug therapy
Neoplasms - mortality
Neoplasms - pathology
Neoplasms - therapy
Prospective Studies
Treatment Outcome
thymopentin
elderly cancer patients
GM-CSF
the PRaG therapy
immunotherapy
radiation therapy
ISSN:1533-0338, 1533-0338
Online-Zugang:Volltext
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Zusammenfassung:Current evidence from evidence-based medicine is limited regarding the efficacy and safety of immunotherapy in elderly patients aged 75 years and older with malignant solid tumors. PRaG therapy, which combines PD-1/PD-L1 inhibitors, radiotherapy, and granulocyte-macrophage colony-stimulating factor (GM-CSF), aims to treat patients with advanced, refractory tumors. Preliminary findings indicate that patients aged 75 years and older can benefit from this treatment and can tolerate it well. This study aims to evaluate the efficacy and safety of the PRaG regimen in elderly patients with advanced malignant solid tumors to provide evidence-based support for immunotherapy in this population. This study involves a multicenter, prospective, single-arm phase II clinical trial designed to enroll 29 patients aged 75 years and older with either newly diagnosed or recurrent metastatic advanced solid tumors that are histologically confirmed. All of the eligible patients will have had to receive at least two cycles of PRaG therapy until disease progression or intolerable adverse effects occurred. The study protocol was approved on September 12, 2023, by the Ethics Committee of the Second Affiliated Hospital of Soochow University (JD-LK-2023-082-I01) and by the ethics committees of all of the participating centers (Trial Registration Number: NCT06112041).
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ISSN:1533-0338
1533-0338
DOI:10.1177/15330338251400412