Меню
Идёт набор NCT07381231

Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors

Фаза II С лечением Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pulse radiation therapy.
Кому может быть актуально
Состояния в реестре: Cancer. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors

Обзор

The goal of this clinical trial is to find out whether Adaptive Pulse Radiotherapy (Pulse RT) combined with immune checkpoint inhibitors (ICIs) helps treat advanced solid tumors. It will also check how safe this combined treatment is and how it affects the immune system and quality of life. The main questions the study will try to answer are: Does adding Pulse RT to ICIs improve tumor response and survival? What side effects occur when participants receive Pulse RT with ICIs? How does the treatment change immune-related blood and tissue markers? Does the treatment affect participants' quality of life? Researchers will compare this new approach to usual ICI treatment to see whether Pulse RT makes a difference. Participants will: Continue to receive their standard ICI treatment. Receive 2-3 sessions of high-dose Pulse RT (8-10 Gy each) given about every 3 weeks. Have the treatment volume adjusted based on how their tumors respond. Visit the clinic regularly for check-ups, imaging, blood tests, and quality-of-life questionnaires.

Вмешательства

  • Лучевая терапия Pulse radiation therapy
    Adaptive Pulse Radiotherapy (Pulse RT) is a personalized radiotherapy strategy designed to enhance anti-tumor immunity when combined with immune checkpoint inhibitors (ICIs). Patients receive 2-3 fractions of 8-10 Gy at 3-4-week intervals, with adaptive modification of target volumes according to tumor response. This approach aims to induce repeated immunogenic cell death and expand tumor-specific T-cell repertoires, thereby amplifying the efficacy of concurrent immunotherapy while maintaining s

Первичные конечные точки

  • Progression-Free Survival at 6 Months [Срок оценки: 6 months after first radiation therapy]
Вторичные конечные точки (6)
  • Progression-Free Survival (PFS) [Срок оценки: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy]
  • Local Recurrence-Free Survival (LRFS) [Срок оценки: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy]
  • Overall Survival (OS) [Срок оценки: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy]
  • Objective Response Rate (ORR) [Срок оценки: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy]
  • Immune Response Profiling and Biomarker Analysis [Срок оценки: Baseline, during treatment, 1 month after last radiation therapy]
  • Change in Patient-Reported Quality of Life [Срок оценки: Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy]

Критерии участия

Критерии включения

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histologically confirmed solid tumor (radiologic diagnosis allowed for hepatocellular carcinoma)
  • Currently receiving or planned to receive immune checkpoint inhibitor (ICI) therapy
  • Presence of at least one lesion suitable for radiotherapy and measurable disease per RECIST version 1.1
  • Ability and willingness to provide written informed consent

Критерии исключения

  • Pregnant or breastfeeding women
  • Presence of brain metastasis or leptomeningeal metastasis
  • Prior radiotherapy to the intended treatment site
  • Significant comorbid conditions that may interfere with study participation or treatment (e.g., uncontrolled infection, heart failure, arrhythmia, psychiatric disorder)
  • Inability or unwillingness to comply with study procedures
  • Considered inappropriate for study participation by the principal investigator or treating physician

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Samsung medical center — Seoul

Идентификаторы

NCT: NCT07381231 · SMC 2025-08-014 · 2025-08-014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗