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Идёт набор NCT06512207

A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer

Без фазы С лечением NSCLC, Stage III NSCLC, Stage IV

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: Leuprorelin acetate + Sintilimab, Sintilimab.
Кому может быть актуально
Состояния в реестре: NSCLC, Stage III, NSCLC, Stage IV. Базовые параметры: от 60 лет · Мужчины.
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

A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer

Обзор

Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Подробное описание

Immune checkpoint blockades (ICBs) are widely used in the clinical treatment of lung cancer. Studies have shown that the quantity and function of tumor-infiltrating lymphocytes (TILs) are associated with the effectiveness of PD-1 inhibitors in treating advanced NSCLC. The thymus is crucial for the differentiation, development, and maturation of T cells. With age, thymic atrophy leads to immunosenescence, significantly affecting baseline anti-tumor immunity and responses to immunotherapies. Preliminary findings have indicated that androgen deprivation therapy (ADT) not only directly induces apoptosis in prostate cancer cells but also may exert anti-tumor effects by promoting thymic regeneration. Furthermore, anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. Therefore, this study aims to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Вмешательства

  • Препарат Leuprorelin acetate + Sintilimab
    Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.
  • Препарат Sintilimab
    PD-1 inhibitor

Первичные конечные точки

  • Number of Participants with Complete Response (CR) [Срок оценки: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Number of Participants with Partial Response (PR) [Срок оценки: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Number of Participants with Disease Progression (PD) [Срок оценки: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Number of Participants with Stable Disease (SD) [Срок оценки: Efficacy evaluations are scheduled at 6 weeks,12 weeks and 18 weeks post treatment]
  • Quantity of Peripheral Blood Lymphocytes [Срок оценки: Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment]
  • Composition of Peripheral Blood Lymphocytes [Срок оценки: Laboratory evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.]
  • Status of Recent Thymic Emigrants (RTEs) [Срок оценки: Evaluations are scheduled before treatment, at 3 weeks post-treatment, and at 6 weeks post-treatment.]

Критерии участия

3.Inclusion Criteria:

  • Male patients aged ≥60 years.
  • ECOG performance status score of 0 \~1.
  • Expected survival time of more than 3 months.
  • Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.
  • Patients who have not previously received any anti-PD-1 treatment.
  • Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.
  • At least one tumor lesion meeting the following criteria:
  • No prior local treatments such as radiotherapy
  • Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy).
  • Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm).
  • If only one measurable lesion, no prior local treatments such as radiotherapy.
  • Ability to understand and voluntarily sign a written informed consent form.
  • Willingness to follow the study protocol and follow-up examinations.

Критерии исключения

  • Exclusion of cases that do not meet the inclusion criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Third Oncology Ward, First Affiliated Hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT06512207 · NSFC-32230037

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗