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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032014
• Other study ID #: 2020ky029
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2021
• Source: Jiangxi Provincial Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 30, 2023
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Other:
• M9
one times a day during the whole treatment
• placebo
placebo

Locations

Country	Name	City	State
China	Chunling Jiang	NanCHang	Jiang XI

Sponsors (2)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital	Inner Mongolia Agricultural University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(objective remission rate)ORR	Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit	6 months
Secondary	PFS	Time from randomness to the first occurrence of disease progression or death from any cause	6 months
Secondary	OS	The time between random onset and the patient's death from any cause	6 months