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Набор скоро начнётся NCT07338396

A Prospective Multicenter Study of the Association Between TCM Syndromes and EGFR-TKI Efficacy in Lung Cancer Patients

— Наблюдательное Non Small Cell Lung Cancer NSCLC

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: EGFR-TKI.
Кому может быть актуально
Состояния в реестре: Non Small Cell Lung Cancer NSCLC. Базовые параметры: от 18 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

A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI

Обзор

The goal of this observational study is to learn about the relationship between TCM body constitution patterns (called "syndromes") and the effectiveness of EGFR-TKI targeted drugs in patients with lung cancer. Approximately 3000 patients with EGFR-mutant non-small cell lung cancer who are about to start or are already taking EGFR-TKI drugs as part of their regular medical care will be invited to join. Participants will be followed for up to 5 years. During routine clinic visits, researchers will collect their TCM information (such as tongue images and pulse readings) and store small samples of their blood, stool, and tongue coating for future research.

Вмешательства

  • Препарат EGFR-TKI
    Standard treatment with EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, osimertinib) for NSCLC. The study observes its association with TCM syndrome patterns.

Первичные конечные точки

  • Progression-Free Survival [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.]
  • Disease-Free Survival [Срок оценки: From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, assessed up to 5 years.]
Вторичные конечные точки (5)
  • Objective Response Rate [Срок оценки: Through study completion, an average of 3 years.]
  • Disease Control Rate [Срок оценки: Through study completion, an average of 3 years.]
  • Overall Survival [Срок оценки: From the date of randomization until the date of death from any cause, assessed up to 5 years.]
  • Quality of life evaluation [Срок оценки: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.]
  • Traditional Chinese Medicine Symptom Assessment [Срок оценки: At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.]

Критерии участия

Критерии включения

  • Pathologically or histologically confirmed non-small cell lung cancer (NSCLC)
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Presence of epidermal growth factor receptor (EGFR) mutation confirmed by genetic testing

Postoperative Cohort (must meet all of the above and the following):

  • Have undergone curative surgery for lung cancer with R0 resection
  • Are planned to receive or are currently receiving postoperative EGFR-TKI adjuvant therapy within 2 weeks

Advanced Cohort (must meet all of the above and the following):

  • Meet stage IIIB-IV criteria according to the 9th edition of the American Joint Committee on Cancer (AJCC), or have stage IIIB or below disease but have refused or are unable to tolerate surgical treatment
  • Have at least one measurable lesion
  • Are planned to receive or are currently receiving first-line EGFR-TKI therapy within 2 weeks

Критерии исключения

  • Unable to comply with baseline assessments
  • Pregnant or breastfeeding women
  • Presence of other uncontrolled malignancies
  • Presence of severe brain diseases or psychiatric disorders that affect the patient's ability to communicate or provide informed consent
  • Individuals without legal capacity, or those with medical or ethical reasons preventing continued participation in the study
  • Refusal to sign the informed consent form

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 6 центров
  • Beijing chest Hospital — Пекин
  • Guang'anmen Hospital of china Academy of chinese Medical Sciences — Пекин
  • Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу
  • Affiliated Hospital of Xinxiang Medical University, Henan province — Weihui
  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine — Шанхай
  • Sichuan Cancer Hospital and Research Institute — Чэнду

Идентификаторы

NCT: NCT07338396 · 2025ZD0544601

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗