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

• ClinicalTrials.gov Identifier: NCT05032014
• Recruitment Status: Unknown
• First Posted: September 2, 2021
• Last Update Posted: October 25, 2021
• Sponsor: Jiangxi Provincial Cancer Hospital
• Collaborator: Inner Mongolia Agricultural University
• Information provided by (Responsible Party): Qiang Xu, Jiangxi Provincial Cancer Hospital

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
Liver Cancer	Other: M9; Other: placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: Probiotics Enhance the Treatment of PD-1 Inhibitors in Patients With Liver Cancer
• Estimated Study Start Date: November 19, 2021
• Estimated Primary Completion Date: December 27, 2022
• Estimated Study Completion Date: December 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: probiotics group; 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; 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 :

1. (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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Karnofsky score ≥90 in patients receiving immunotherapy for liver 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

China, Jiang XI

Chunling Jiang; Recruiting

NanCHang, Jiang XI, China

Contact: Chunling Jiang, doctor 13979109200 ext +086 jclil2002@163.com

Sponsors and Collaborators

Jiangxi Provincial Cancer Hospital

Inner Mongolia Agricultural University

More Information

• Responsible Party: Qiang Xu, Chief Physician, Jiangxi Provincial Cancer Hospital
• ClinicalTrials.gov Identifier: NCT05032014
• Other Study ID Numbers: 2020ky029
• First Posted: September 2, 2021
• Last Update Posted: October 25, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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