Probiotics With High Expression of DL-peptidase (LR607) Can Enhance the Efficacy of Chemoradiotherapy in Resectable Stage IIB-IIIB Non-small Cell Lung Cancer: a Single-arm, Open-label, Multicenter, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Major pathological response
研究概览
简要总结
The goal of this clinical trial is to understand whether Lactobacillus rhamnosus LR607 can enhance neoadjuvant chemoimmunotherapy for adult patients with non-small cell lung cancer. It will also evaluate the safety of LR607. The main questions it aims to answer include:
Can LR607 improve the major pathological response of neoadjuvant chemoimmunotherapy? What is the relationship between LR607 combined with neoadjuvant chemoimmunotherapy and treatment-related adverse reactions? What changes occur in the gut microbiota composition at the species level and gut metabolites of subjects after LR607 treatment?
Participants will:
Take LR607 daily for 3 months Visit the hospital for check-ups and examinations every month Record their pathological response, tumor recurrence, and treatment-related adverse reactions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed newly diagnosed patients
- •ECOG performance status 0-1
- •Age ≥18 years
- •Measurable lesions (RECIST v1.1)
- •Organ function meeting the requirements for chemotherapy and immunotherapy.
排除标准
- •Including active autoimmune diseases
- •Recent use of immunosuppressants
- •Interstitial lung disease
- •Presence of other malignancies
- •History of immunotherapy
- •Active infection
- •Pregnancy or drug allergies
研究组 & 干预措施
Probiotics combined with neoadjuvant chemoimmunotherapy
干预措施: Probiotics combined with neoadjuvant chemoimmunotherapy (Drug)
结局指标
主要结局
Major pathological response
时间窗: Day 1 to 4 weeks
Major pathological response (MPR) was defined as ≤10% residual viable tumor cells in the tumor bed on pathological examination of the resected specimen in enrolled patients who underwent surgery within approximately 1 week after completion of three cycles of neoadjuvant therapy with a PD-1/PD-L1 inhibitor plus LR607 and platinum-based doublet chemotherapy (approximately 63 days).
次要结局
- Pathological Complete Response(Day 1 to 4 Weeks)