NCT06613308尚未招募不适用
Association Between Respiratory Tract and Gut Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable Non-small-cell Lung Cancer: a Single-center Cohort Study
Capital Medical University0 个研究点目标入组 20 人开始时间: 2024年9月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Major pathological response (mPR)
研究概览
简要总结
This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •first-diagnosed, driver gene-negative non-small cell lung cancer patients with histopathological confirmed diagnosis (Stage IIA-IIIB);
- •at least 1 measurable lesion as defined by RECIST version 1.1; an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1;
- •no prior systemic therapy or radiotherapy;
- •the patients are eligible for indications for surgical resection and amenable to - neoadjuvant immunotherapy or chemotherapy after multidisciplinary evaluation;
- •signing the written consent before enrollment in the study;
- •participants need to have adequate pulmonary ventilation and diffusion function to allow surgical resection by pre-enrolment pulmonary function testing;
排除标准
- •refusal of participation or inability to give a clear consent;
- •requiring treatment with systemic glucocorticoids and other - immunosuppressive agents;
- •use of antibiotics within the previous 3 months or the presence of an infectious disease requiring antibiotic therapy;
- •probiotics within 3 months prior to enrolment;
- •presence of obstructive pneumonia, cancerous cavities, active tuberculosis;
- •the presence of bronchiectasis, combined lung infections, pulmonary fibrosis, uncontrolled diabetes mellitus;
- •the presence of primary tumors elsewhere;
- •receiving chemotherapy or any other cancer treatment prior to enrolment;
- •participants with brain metastases confirmed by brain MRI with contrast prior to enrolment;
- •active or pre-existing autoimmune disease;
- •the presence of uncontrolled comorbidities, including heart failure, uncontrolled hypertension, unstable angina, interstitial lung disease;
- •positive test for hepatitis B surface antigen or hepatitis C ribonucleic acid requiring treatment;
- •known positive history or positive test results for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
- •history of allergy to study drug components;
- •women who are pregnant or breastfeeding;
- •previous treatment with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibodies.
研究组 & 干预措施
Arm1(Neoadjuvant immunotherapy combined with chemotherapy)
干预措施: Neoadjuvant immunotherapy combined with chemotherapy (Drug)
Arm2(Neoadjuvant chemotherapy)
干预措施: Neoadjuvant chemotherapy (Drug)
结局指标
主要结局
Major pathological response (mPR)
时间窗: Whithin time from enrollment to surgery
defined as ≤10% residual live tumor tissue in lung cancer samples resected after neoadjuvant therapy as assessed by the central pathology laboratory.
次要结局
- Pathologic complete response (pCR)(Whithin time from enrollment to surgery)
- Disease free survival (DFS)(Whithin 1 year after surgery)
- Overall survival (OS)(Whithin 1 year after enrollment)
- Immune-related adverse event (irAE)(Whithin 1 year after enrollment)
- Changes in microbiomics in respiratory tract and gut(Whithin 1 year after enrollment)
- Radiological response(Whithin time from enrollment to surgery)
- Changes in single-cell immune repertoire(Whithin time from enrollment to surgery)
研究者
Bin Cao
M.D.
China-Japan Friendship Hospital
相似试验
已完成
不适用
Lung and Gut Microbiome in Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT03310164Peking University Third Hospital120
Unknown
不适用
A Study of the Relationship of Gut Microbial Composition and Stroke OutcomeIschemic StrokeNCT03470506University of Virginia300
Unknown
不适用
Microbiome and Papillary Thyroid MicrocarcinomaMicrobiomePapillary Thyroid MicrocarcinomaNCT04376203University of Ioannina40
招募中
不适用
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant AsthmaAsthma in ChildrenAsthmaNCT06044051University Hospital, Rouen100
已完成
不适用
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 VaccineInflammatory Bowel DiseasesNCT05584735University of Wisconsin, Madison46