NCT05032014

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

Status unknown NA Last updated 25 October 2021

What this trial tests

NA trial testing M9 in Liver Cancer in 46 participants. Status unknown.

Timeline

19 November 2021

Primary endpoint
27 December 2022

30 December 2023

Quick facts

Lead sponsor	Jiangxi Provincial Cancer Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	46
Start date	19 November 2021
Primary completion	27 December 2022
Estimated completion	30 December 2023
Sites	1 location across China

Drugs / interventions tested

• M9
• placebo

Conditions studied

• Liver Cancer — all drugs for Liver Cancer →

Sponsor

Jiangxi Provincial Cancer Hospital

Who can join

Adults 18 to 70, any sex, with Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of the gut microbiota in anticancer therapy: from molecular mechanisms to clinical applications.
   Zhao LY, Mei JX, Yu G, Lei L, et al · · 2023 · cited 211× · PMID 37179402 · DOI 10.1038/s41392-023-01406-7
2. Gut microbiome in modulating immune checkpoint inhibitors.
   Li X, Zhang S, Guo G, Han J, et al · · 2022 · cited 113× · PMID 35841869 · DOI 10.1016/j.ebiom.2022.104163
3. The role of Lactobacillus in inflammatory bowel disease: from actualities to prospects.
   Li C, Peng K, Xiao S, Long Y, et al · · 2023 · cited 109× · PMID 37773196 · DOI 10.1038/s41420-023-01666-w
4. Role of gut microbiome in cancer immunotherapy: from predictive biomarker to therapeutic target.
   Zhang M, Liu J, Xia Q. · · 2023 · cited 77× · PMID 37770953 · DOI 10.1186/s40164-023-00442-x
5. Modulating gut microbiome in cancer immunotherapy: Harnessing microbes to enhance treatment efficacy.
   Kang X, Lau HC, Yu J. · · 2024 · cited 65× · PMID 38631285 · DOI 10.1016/j.xcrm.2024.101478
6. The role of the gut microbiota in tumor, immunity, and immunotherapy.
   Xie Y, Liu F. · · 2024 · cited 37× · PMID 38903520 · DOI 10.3389/fimmu.2024.1410928
7. Gut microbiome homeostasis and the future of probiotics in cancer immunotherapy.
   Singh A, Alexander SG, Martin S. · · 2023 · cited 35× · PMID 37261348 · DOI 10.3389/fimmu.2023.1114499
8. Gut microbiota shapes cancer immunotherapy responses.
   Lei W, Zhou K, Lei Y, Li Q, et al · · 2025 · cited 33× · PMID 40715107 · DOI 10.1038/s41522-025-00786-8