This study will analyze the composition and diversity of the gut microbiota of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) through metagenomic high-throughput sequencing methods, and explore the relationship between the gut microbiota and anti-PD-1/PD-L1 treatment response. This study will further understand the influence and mechanism of the gut microbiota on tumor immunotherapy, and will provide new ideas and theoretical basis for improving the efficacy of tumor immunotherapy by targeting the gut microbiota in the clinic, and benefit more NSCLC patients.
Study Type
OBSERVATIONAL
Enrollment
50
Response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment.
Non response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGDiversity and Composition of gut microbiota
The difference of gut microbiota diversity and composition between Responder group with Non-Responder group. Microbiota diversity will be quantified by α-diversity ( Faith's Phylogenetic Diversity) based on meta-genomics sequencing. Microbiota composition will be quantified by the operational taxonomic unit (OTU) in the stool.
Time frame: At the end of Cycle 4 (each cycle is 21 days)
Concentration of peripheral blood mononuclear cells
The difference of composition and content of peripheral blood mononuclear cells (CD8+T-cells, NK cells and myelin-sourced inhibitory cells) between Responder group with Non-Responder group. The composition and content of CD8+T-cells, NK cells and myelin-sourced inhibitory cells were analyzed by flow cytometry.
Time frame: At the end of Cycle 4 (each cycle is 21 days)
Concentration of tumor immune related cytokines
The difference of the contents of tumor immune related cytokines (IFNγ、TNF、Granzyme A/B、Perforin and et al)between Responder group with Non-Responder group. The contents of tumor immune related cytokines were analyzed by enzyme-linked immunosorbent assay.
Time frame: At the end of Cycle 4 (each cycle is 21 days)
Incidence of anti-PD-1/PD-L1 related adverse events
Number of patients with adverse events that received anti-PD-1/PD-L1 treatment
Time frame: through study completion, up to 2 years
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