A Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Non-Small Cell Lung Cancer. 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Construction of a Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
Обзор
The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications.
Подробное описание
Lung cancer remains the leading cause of cancer-related mortality in China and globally, imposing a substantial disease burden on society. Although comprehensive treatment strategies centered on surgery have improved patient outcomes, and perioperative immunotherapy-particularly immune checkpoint inhibitors-has profoundly reshaped the therapeutic landscape, significant knowledge gaps and critical challenges persist in this field. These challenges include uncertain beneficiary populations, poorly understood immune mechanisms, inaccurate efficacy prediction, difficult determination of resection margins, controversial efficacy assessment, and lack of effective early warning for adverse reactions.
This study will systematically identify biomarkers for early diagnosis and recurrence monitoring through multi-omic analysis of peripheral blood immune cell subsets and non-invasive liquid biopsies; investigate the tumor immune microenvironment's role in immunotherapy response mechanisms and predict treatment efficacy via multi-omic studies of tissue specimens; develop novel AI- and radiomics-assisted pathological assessment systems and prognostic prediction models; implement perioperative symptom assessment for timely identification of immune-related adverse events (irAEs) while conducting prehabilitation training for perioperative nursing care.
Первичные конечные точки
- Pathological Complete Response (pCR) [Срок оценки: At surgery (typically 3-6 months post-treatment initiation)]
Вторичные конечные точки (8)
- Major Pathological Response (MPR) [Срок оценки: At surgery (typically 3-6 months post-treatment initiation)]
- Objective Response Rate (ORR) [Срок оценки: After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).]
- Recurrence-free Survival (RFS) [Срок оценки: Through study completion, an average of 2 years]
- Overall Survival (OS) [Срок оценки: Through study completion, an average of 2 years]
- MRD (minimal residual disease) dynamics after neoadjuvant immunotherapy [Срок оценки: Periprocedural and every three to six months post-treatment (up to three years)]
- Symptom Severity Score [Срок оценки: Preoperative (T1: 2-4 weeks pre-surgery), postoperative (e.g., T3: 12-24 hours post-surgery, T5: 30 days post-surgery), and up to 90 days post-surgery.]
- Immune-Related Adverse Event (irAE) Incidence [Срок оценки: Periprocedural and up to 6 months post-treatment.]
- Changes in PD-L1 expression (TPS) and TIL subpopulations (CD8+/FOXP3+ ratios, et al) before and after neoadjuvant immunotherapy [Срок оценки: Periprocedural.]
Критерии участия
Критерии включения
- Age ≥ 18 years old;
- NSCLC patients underwent radical surgical resection;
- Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
- Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.
Критерии исключения
- Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
- Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
- Pregnancy or lactation;
- Insufficient sample quality;
- Severe organ dysfunction (e.g. cardiac or renal insufficiency);
- Other judgments by the Investigator that the patient should not participate in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07119190 · BRWEP2024W034080200