- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05094167
Lactobacillus Bifidobacterium V9(Kex02)Improving the Efficacy of Carilizumab Combined With Platinum in Non-small Cell Lung Cancer Patients
October 17, 2021 updated by: Qiang Xu, Jiangxi Provincial Cancer Hospital
The Mechanism of Probiotic Lactobacillus Bifidobacterium V9(Kex02)Improving the Efficacy of Carilizumab Combined With Platinum in Non-small Cell Lung Cancer Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiang XI
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NanCHang, Jiang XI, China
- Recruiting
- Chunling Jiang
-
Contact:
- Chunling Jiang, doctor
- Phone Number: +086 13979109200
- Email: jclil2002@163.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: healthy control group
|
|
Placebo Comparator: placebo group
Immunotherapy with placebo alone
|
placebo
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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.
|
one times a day during the whole treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(objective remission rate)ORR
Time Frame: 6 months
|
Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 6 months
|
The time between random onset and the patient's death from any cause
|
6 months
|
PFS
Time Frame: 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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 19, 2021
Primary Completion (Anticipated)
December 27, 2022
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
October 17, 2021
First Submitted That Met QC Criteria
October 17, 2021
First Posted (Actual)
October 26, 2021
Study Record Updates
Last Update Posted (Actual)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 17, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JCL2021-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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