The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)

Официальное название

The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors(PRaG9.0)

Обзор

This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.

Вмешательства

• Препарат ADC Combined With Radiotherapy, PD-L1 Sequential GM-CSF and Thymopentin
  RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin

Первичные конечные точки

• Objective Response Rate #ORR# [Срок оценки: 36 months]

Вторичные конечные точки (4)

• Progression-free Survival (PFS) [Срок оценки: 36 months]
• Disease control rate (DCR) [Срок оценки: 36 months]
• Overall survival (OS) [Срок оценки: 36 months]
• Adverse event [Срок оценки: 36 months]

Критерии участия

Критерии включения

• Aged 75 years and above
• Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy
• ECOG(Eastern Cooperative Oncology Group) performance is 0-3
• Life expectancy greater than 3 months
• serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0\*ULN, or AST and ALT≤5\*ULN with hepatic metastasis; Total serum creatinine ≤1.5\*ULN
• Signed informed consent form

Критерии исключения

• Current pregnancy or lactation
• History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer)
• Uncontrolled epilepsy, central nervous system diseases or mental illness
• arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study
• Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation
• Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes
• Allergic to any of the ingredients used in the study
• A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy
• Acute and chronic tuberculosis infection
• Other disorders with clinical significance according to the researcher's judgment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Second Affiliated Hospital of Soochow University — Сучжоу

Публикации

• Zhao X, Yang M, Zhang J, Kong Y, Xu M, Chen R, Yin Q, Wang S, Chen G, Xing P, Zhang L. Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study). Technol Cancer Res Treat. 2025 Jan-Dec;24:15330338251400412. doi: 10.1177/15330338251400412. Epub 2025 Nov 27. PMID 41308040

Идентификаторы

NCT: NCT06112041 · JD-LK2023082-I01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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