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Набор скоро начнётся NCT05822284

ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy

— Наблюдательное Non-small Cell Lung 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: NGS and ctDNA-MRD detection.
Кому может быть актуально
Состояния в реестре: Non-small Cell Lung Cancer. Базовые параметры: 18 лет — 75 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
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Официальное название

The Role of Dynamic Circulating Tumor DNA-Molecular Residual Disease (ctDNA-MRD) Testing in Stage IIIB-C Oncogene-negative NSCLC Patients Treated With Induction Chemoimmunotherapy in the Multidisciplinary Team (MDT) Model of Diagnosis and Treatment

Обзор

The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.

Подробное описание

This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for next-generation sequencing (NGS) of institutionally-developed 1021-gene panel, and personalized detection panel will be customized based on NGS testing results. Patients will be received induction chemoimmunotherapy followed by surgery or non-surgical treatment in the MDT model and ctDNA-MRD testing will be performed at prespecified time points. For patients who received surgery following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery and landmark time and pulmonary venous blood will be collected intraoperatively. For patients who received non-surgical treatment following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before non-surgical therapy and landmark time. All included patients will be regularly followed up for at least 5 years.

Вмешательства

  • Диагностический тест NGS and ctDNA-MRD detection
    NGS and ctDNA-MRD detection

Первичные конечные точки

  • Predicting Progression Free Survival [Срок оценки: up to 5 years]
  • Predicting pathologic complete response [Срок оценки: Up to 1 year]
  • Predicting Overall Survival [Срок оценки: up to 5 years]
Вторичные конечные точки (6)
  • Objective response rate(ORR) [Срок оценки: Up to 1 year]
  • Adverse events (AEs) [Срок оценки: Up to 5 years]
  • Perioperative complications rate [Срок оценки: Up to 3 years]
  • Health-related Quality of Life [Срок оценки: Up to 5 years]
  • Perioperative pain evaluation [Срок оценки: Up to 3 years]
  • Lung cancer-related Quality of Life [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Histopathology or cytology confirmed the non-small cell lung cancer
  • Age ranging from 18 to 75
  • Agree to participate in this study and sign an informed consent form
  • Treatment-naive tumor
  • Driver gene negativity
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor
  • The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1

Критерии исключения

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
  • Small cell lung cancer
  • Driver gene positivity
  • Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
  • Patients with solid organ or blood system transplantation
  • Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors
  • Patients with interstitial lung disease
  • Patients with acute or chronic infectious disease
  • Pregnant and lactating women
  • Patients who have undergone other clinical drug trials

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 · 1 центр
  • Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China — Чанша

Идентификаторы

NCT: NCT05822284 · LYF2023026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗