Lactobacillus Bifidobacterium V9(Kex02)Improving the Efficacy of Carilizumab Combined With Platinum in Non-small Cell Lung Cancer Patients

Jiangxi Provincial Cancer Hospital

Status: Unknown

Conditions: Non-small Cell Lung Cancer

Treatments: Other: V9; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05094167

JCL2021-10

Details and patient eligibility

About

Human microbes have been called "the second genome of humanity".On May 13,2016,the White House launched the National Microbiome Initiative (NMI), with an estimated investment of us $521 million, to elevate microbiome research to a national strategic status. The gut is the largest microecological environment in the human body. The research in the field of intestinal microbiome has become one of the most advanced and hot research directions in the scientific field of the world today. At present, more than 50 diseases have been found to be related to intestinal microbiome disorders. Pd-1 (programmed death receptor 1) is an important immunosuppressive molecule.It regulates the immune system and promotes tolerance by down-regulating the immune system's response to human cells and by suppressing T cell inflammatory activity. In the past, the research team and colleagues in related fields have found a strong correlation between Gut Microbiome and the efficacy of anti-PD-1 immunotherapy in cancer patients.This protects against autoimmune diseases, but it also prevents the immune system from killing cancer cells. As more and more scientific evidence shows that intervention of human intestinal flora may improve the efficacy of anti-PD-1 immunotherapy in tumor patients, intestinal flora, as the most effective way to intervene human intestinal flora, has been mentioned by many research institutions and international drug manufacturers in combination with anti-PD-1.Our previous study showed that the abundance of beneficial bacteria such as lactic acid bacteria, bifidobacteria and Akkermansia Muciniphila was significantly correlated with pD-1 inhibitor response, and regulating the intestinal flora content could improve the effect of PD-1 inhibitor on mouse tumors, indicating that microbial flora was involved in regulating cancer immunotherapy.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Karnofsky score ≥90 in patients receiving immunotherapy for non-small cell lung cancer at our cancer center

Exclusion criteria

• any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to V9

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups, including a placebo group

probiotics group

Experimental group

Description:

The oral probiotic (Lactobacillus Bifidobacterium V9,one times a day during the whole treatment) was isolated from healthy women's breast milk samples in 2017 and was identified as Lactobacillus rhamnosus by physiological and biochemical and 16S rRNA. It is listed as the "List of Probiotics for Health Food" in my country's "List of Bacteria Available for Food", which can be directly applied to food production.

Treatment:

Other: V9

placebo group

Placebo Comparator group

Description:

Immunotherapy with placebo alone

Treatment:

Other: placebo

healthy control group

No Intervention group

Description:

healthy control group