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Идёт набор NCT05455034

Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

Фаза I / Фаза II С лечением Pneumonitis

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: single-cell sequencing.
Кому может быть актуально
Состояния в реестре: Pneumonitis. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Single-cell Sequencing of Bronchoalveolar Lavage Fluid to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

Обзор

A multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

Подробное описание

This study is a multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

Вмешательства

  • Генная терапия single-cell sequencing
    Treatment is given according to the results of single-cell sequencing.

Первичные конечные точки

  • Response rate [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written informed consent;
  • NSCLC patients who have been clinically diagnosed with RP or CIP after histopathologically confirmed radiotherapy or immunocheckpoint inhibitor treatment and have not received glucocorticoid or other drugs.
  • ≥18 years old, less than 75 years old;
  • ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
  • Patients without contraindications to alveolar lavage;

Критерии исключения

  • Poor patient compliance and violation of test regulations;
  • Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
  • Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
  • Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
  • Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
  • Untreated patients with chronic hepatitis B, HBV carriers with HBV DNA≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \& LT; 500 IU/mL), patients with cured hepatitis C could be enrolled;
  • Known history of HIV infection;
  • Received any other investigational drug or participated in any other clinical trial within 28 days.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Xinqiao Hospital — Чунцин

Публикации

  • Papalexi E, Satija R. Single-cell RNA sequencing to explore immune cell heterogeneity. Nat Rev Immunol. 2018 Jan;18(1):35-45. doi: 10.1038/nri.2017.76. Epub 2017 Aug 7. PMID 28787399
  • Liao M, Liu Y, Yuan J, Wen Y, Xu G, Zhao J, Cheng L, Li J, Wang X, Wang F, Liu L, Amit I, Zhang S, Zhang Z. Single-cell landscape of bronchoalveolar immune cells in patients with COVID-19. Nat Med. 2020 Jun;26(6):842-844. doi: 10.1038/s41591-020-0901-9. Epub 2020 May 12. PMID 32398875
  • Grun D, van Oudenaarden A. Design and Analysis of Single-Cell Sequencing Experiments. Cell. 2015 Nov 5;163(4):799-810. doi: 10.1016/j.cell.2015.10.039. PMID 26544934

Идентификаторы

NCT: NCT05455034 · XQonc-019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗