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Идёт набор NCT06790797

Investigating the Biomarkers in Tumor and Peripheral Blood to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients

— Наблюдательное Lung Cancer Esophageal 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: In vitro stimulation of Pbmc with tumor antigen nanoparticles.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Esophageal Cancer. 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

Investigating the Biomarkers in Tumor Microenvironment and Peripheral Blood Microenvironment to Evaluate the Efficacy of Cancer Immunotherapy in Chest Cancer Patients

Обзор

This study aims to investigate the impact of immunotherapy on the immune status of tumor microenvironment and peripheral blood of chest cancer patients. To do so, the investigators plan to collect tumor tissue and peripheral blood samples before and after immunotherapy, and use single-cell RNA sequencing, Multiplex immunohistochemistry, and flow cytometry. The investigators will analyze changes in the proportion of cancer cell-specific T-cell subpopulations related to treatment response before and after therapy, and seek biological markers that can predict the efficacy of immunotherapy.

Подробное описание

The potential biomarkers, that can be utilized to predict the efficacy of cancer immunotherapy, in tumor tissue and peripheral blood are planning to be verified in lung cancer patients and esophageal cancer patients. Tumor tissues, acquired from surgery to remove tumor, are investigated by single-cell RNA sequencing, Multiplex immunohistochemistry etc. to explore the biomarkers. In addition, immune microenvironment of the peripheral blood mononuclear cells were analyzed by flow cytometry and ELISPOT to quantify specific T cells groups that are correlated with efficacy of cancer immunotherapy. The changes in the proportion of specific T-cell subpopulations that can kill cancer cells will be analyzed before treatment and after treatment. The immunotherapy responses before and after therapy are planning to analyzed with the content of specific T cells. Thus the investigators will seek biological markers that can predict the efficacy of immunotherapy.

Вмешательства

  • Другое In vitro stimulation of Pbmc with tumor antigen nanoparticles
    PBMCs were isolated from peripheral blood of cancer patients, and PBMC are co-incubated with nanoparticles loading tumor antigens for specific time in vitro to detect T cells that are related with efficacy of cancer immunotherapy. The content of such T cells are studies the correlation with the efficacy of cancer immunotherapy and patient prognosis.

Первичные конечные точки

  • The changes of immune cell subsets in tumor microenvironment and peripheral blood in patients [Срок оценки: Within one month of completing immunotherapy]
Вторичные конечные точки (1)
  • Exploring the feasibility of tumor-specific T cells as a biomarker for predicting the efficacy of immunotherapy: the absolute amount and proportion of tumor antigen specific T cells are increased in patients that response to cancer immunotherapy [Срок оценки: Within one month of completing immunotherapy]

Критерии участия

Критерии включения

  • Patients with a pathological diagnosis of lung cancer or esophageal cancer who have agreed to receive PD-1/PD-L1 antibody immunotherapy;
  • Age between 18 and 80 years old;
  • ECOG PS score of 0 or 1;
  • Adequate organ and bone marrow function;
  • Anticipated survival time of at least 12 weeks;
  • Willing and able to provide written informed consent.

Критерии исключения

  • Patients with hematogenic infectious diseases, such as HIV, hepatitis B or hepatitis C.
  • Patients with tumor emergencies that require immediate treatment.
  • Poor vascular conditions.
  • Abnormal coagulation function or receiving anticoagulant or thrombolytic therapy.
  • Patients with hematogenic infectious diseases, such as HBV.
  • Patients with psychiatric disorders or severe mental illnesses.
  • Patients who have difficulty communicating or are unable to be followed up for a long time.
  • Other situations that are not suitable for inclusion in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • The first affiliated hospital of soochow university — Сучжоу

Идентификаторы

NCT: NCT06790797 · 2024727

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗