Меню
Набор скоро начнётся NCT07752589

Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC

— Наблюдательное Non-Small Cell Carcinoma of Lung Gut Microbiomes Neoadjuvant Chemoimmunotherapy

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: Neoadjuvant chemoimmunotherapy.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Carcinoma of Lung, Gut Microbiomes, Neoadjuvant Chemoimmunotherapy. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Prospective Cohort Study Investigating Gut Microbiota as an Immunomodulatory Predictor of Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-small-cell Lung Cancer

Обзор

Locally advanced lung cancer (LALC) has poor prognosis despite multimodal therapies. Neoadjuvant chemoimmunotherapy is now standard for resectable stage II-IIIB NSCLC, but patient responses vary. The gut microbiota, a key immune regulator, has been linked to immunotherapy efficacy, with microbial diversity predicting ICI response and fecal microbiota transplantation improving outcomes. While most studies focus on advanced disease, the microbiota's role in LALC during neoadjuvant therapy remains unclear. Exploring its dynamics may uncover novel biomarkers and strategies to optimize treatment

Вмешательства

  • Препарат Neoadjuvant chemoimmunotherapy
    neoadjuvant chemoimmunotherapy typically involves a PD-1 inhibitor-such as nivolumab, sintilimab, or camrelizumab-combined with platinum-based doublet chemotherapy (e.g., paclitaxel plus cisplatin for squamous cell carcinoma, or pemetrexed plus cisplatin for adenocarcinoma). The standard regimen includes three treatment cycles administered every three weeks, followed by surgical resection within 4-6 weeks. Some patients may receive up to one year of adjuvant immunotherapy postoperatively.

Первичные конечные точки

  • Pathologic complete response (pCR) [Срок оценки: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）]
Вторичные конечные точки (5)
  • Major pathological response (MPR) [Срок оценки: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）]
  • Radiological response [Срок оценки: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）]
  • Immune-related adverse event (irAE) [Срок оценки: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）]
  • gut microbiomes [Срок оценки: From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）]
  • Disease free survival (DFS） [Срок оценки: From the postoperative period through 1 year after surgery]

Критерии участия

Критерии включения

  • Age between 18 and 80 years;
  • Newly diagnosed, driver gene-negative non-small cell lung cancer (NSCLC) confirmed by histopathology (Stage IIA-IIIB);
  • At least one measurable lesion as defined by RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • No prior systemic therapy or radiotherapy;
  • Eligible for surgical resection and suitable for neoadjuvant immunotherapy or chemotherapy as determined by multidisciplinary evaluation;
  • Signed written informed consent prior to study participation;
  • Adequate pulmonary ventilation and diffusion function confirmed by pre-enrollment pulmonary function test to allow for surgical resection.

Критерии исключения

  • Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments;
  • Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months;
  • Probiotic use within 3 months prior to enrollment;
  • Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis;
  • Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus;
  • Presence of a primary tumor in another organ;
  • Receipt of chemotherapy or any other cancer treatment prior to enrollment;
  • Confirmed brain metastases by contrast-enhanced MRI before enrollment;
  • Active or pre-existing autoimmune diseases;
  • Uncontrolled comorbidities including heart failure, uncontrolled hypertension, unstable angina, or interstitial lung disease;
  • Positive for hepatitis B surface antigen or detectable hepatitis C RNA requiring treatment;
  • Known history or positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
  • Pregnant or breastfeeding women;
  • Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07752589 · KY2025-810-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗