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

Sponsor

Jiangxi Provincial Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05094167

Collaborator

Inner Mongolia Agricultural University (Other)

Enrollment

Location

Arms

26.3

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Other: V9 Other: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The random assignment of patients was performed by Nanchang Medical University with a computer-generated random number code. Patients were randomly distributed in a 1:1 ratio to receive probiotics or a placebo (the block size was known only to the statistician). The drug was distributed and packaged in accordance with random numbers, and the documents stating the parameters, such as the blinding codes for the seeds of the random numbers, the block length, and the random numbers, were sealed in envelopes

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Dec 27, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: probiotics group 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.	Other: V9 one times a day during the whole treatment
Placebo Comparator: placebo group Immunotherapy with placebo alone	Other: placebo placebo
No Intervention: healthy control group healthy control group

Arm

Intervention/Treatment

Experimental: probiotics group

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.

Other: V9

one times a day during the whole treatment

Placebo Comparator: placebo group

Immunotherapy with placebo alone

Other: placebo

placebo

No Intervention: healthy control group

healthy control group

Outcome Measures

Primary Outcome Measures

(objective remission rate)ORR [6 months]
Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit

Secondary Outcome Measures

PFS [6 months]
Time from randomness to the first occurrence of disease progression or death from Time from randomness to the first occurrence of disease progression or death from any cause
OS [6 months]
The time between random onset and the patient's death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chunling Jiang	NanCHang	Jiang XI	China

Sponsors and Collaborators

Jiangxi Provincial Cancer Hospital
Inner Mongolia Agricultural University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qiang Xu, Chief Physician, Jiangxi Provincial Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05094167

Other Study ID Numbers:

JCL2021-10

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Oct 26, 2021