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

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: Liver Cancer
• Intervention / Treatment: Other: placebo; Other: M9

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiang XI
    • NanCHang, Jiang XI, China
      • Recruiting
      • Chunling Jiang
      • Contact: Chunling Jiang, doctor; Phone Number: +086 13979109200; Email: jclil2002@163.com

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: healthy control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(objective remission rate)ORR	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
PFS	Time from randomness to the first occurrence of disease progression or death from any cause	6 months
OS	The time between random onset and the patient's death from any cause	6 months

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital
• Collaborators: Inner Mongolia Agricultural University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 19, 2021
• Primary Completion (Anticipated): December 27, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2020ky029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No