Probiotics Enhance the Treatment of PD-1 Inhibitors in Patients With Liver Cancer

NCT05032014 | Unknown

• 1 other identifier: 2020ky029
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• (objective remission rate)ORR

  Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit

  6 months

Secondary Outcomes (2)

• PFS

  6 months

• OS

  6 months

Study Arms (3)

probiotics group

EXPERIMENTAL

The oral probiotic (Lactobacillus rhamnosus Probio-M9,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: M9

placebo group

PLACEBO COMPARATOR

Immunotherapy with placebo alone

Other: placebo

healthy control group

NO INTERVENTION

healthy control group

Interventions

M9 OTHER

one times a day during the whole treatment

probiotics group

placebo OTHER

placebo

placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky score ≥90 in patients receiving immunotherapy for liver cancer at our cancer center

You may not qualify if:

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

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead
• Inner Mongolia University of Science and Technology: collaborator

Study Sites (1)

Chunling Jiang

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: September 2, 2021
• Study Start: November 19, 2021
• Primary Completion: December 27, 2022
• Study Completion: December 30, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

CN (1)