In this study, patients with locally advanced or metastatic NSCLC after first-line treatment with PD-1/PDL-1 monoclonal antibody will be treated with Gut Microbiota reconstruction(such as FMT) combined with PD-1/PDL-1 monoclonal antibody. We will evaluate the safety of FMT in the treatment of advanced NSCLC, and analyze the effect of FMT on intestinal flora and immunophenotype of patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Capsules contained washed fecal microbiota.
Standard dose of one of anti-PD-1/PD-L1 mAbs administered as a 1 hour infusion every 3 weeks.
Standard dose of Platinum based Chemotherapy every 3 weeks.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Incidence of FMT-related Adverse Events
Number of patients with adverse events after FMT
Time frame: 2 years
Incidence of anti-PD-1/PD-L1-related Adverse Events
Number of patients with adverse events related to anti-PD-1/PD-L1 after FMT
Time frame: 2 years
Changes in diversity and composition of gut microbiota
Compare the difference of gut microbiota diversity and composition between pre-FMT and post-FMT samples. 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: 2 years
Efficiency of FMT engraftment
Evaluate the acquired similarity of the recipient microbiota to the donor microbiota by measuring the Euclidian distance between donor microbial composition and every available time point of the corresponding recipients, starting from the pre-FMT sample.
Time frame: 2 years
Changes in concentration of peripheral blood mononuclear cells
Compare composition and content of peripheral blood mononuclear cells (CD8+T-cells, NK cells and myelin-sourced inhibitory cells) between pre-FMT and post-FMT samples. The composition and content of CD8+T-cells, NK cells and myelin-sourced inhibitory cells were analyzed by flow cytometry.
Time frame: 2 years
Changes in concentration of tumor immune related cytokines
Compare the contents of tumor immune related cytokines (IFNγ、TNF、Granzyme A/B、Perforin and et al) between pre-FMT and post-FMT samples. The contents of tumor immune related cytokines were analyzed by enzyme-linked immunosorbent assay.
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Time frame: 2 years
Objective response rate (ORR)
Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST
Time frame: 2 years