A Prospective Cohort Study Investigating Gut Microbiota as an Immunomodulatory Predictor of Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-small-cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Response Group
a complete or partial response or stable disease lasting >6 months were classified as responders
干预措施: Neoadjuvant chemoimmunotherapy (Drug)
Non-Response Group
patients who progressed on therapy or had stable disease <6 months were classified as non-responders
干预措施: Neoadjuvant chemoimmunotherapy (Drug)
结局指标
主要结局
Pathologic complete response (pCR)
时间窗: From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）
Pathological complete response (pCR) is defined as the absence of any residual invasive cancer in the resected primary tumor and lymph nodes following neoadjuvant therapy, as assessed by histopathological examination
次要结局
- Major pathological response (MPR)(From surgery to the end of the 1-month postoperative （periodPerioperative/Periprocedural）)
- Radiological response(From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）)
- Immune-related adverse event (irAE)(From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）)
- gut microbiomes(From the time of enrollment through the completion of surgery（Perioperative/Periprocedural）)
- Disease free survival (DFS）(From the postoperative period through 1 year after surgery)
研究者
Wen-zhao ZHONG
Chief Physician
Guangdong Provincial People's Hospital