Clinical Trial

Gut Microbiota (GM) Biodiversity in Patients With Solid Tumors Treated With Immune Checkpoint Inhibitors (ICIs): a Monocenter Prospective Study to Identify the Interactions Between GM and ICIs

Study acronym: GM&ICI
Active, Not Recruiting
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Summary
Although it is a milestone in the treatment of solid neoplasms, Immunotherapy (ICI) is still burdened by low response rate to the treatment and the occurrence of immune-related adverse events (irAEs). Recently, many studies have suggested that the The diversity of the intestinal microbiota (GM) can modulate response to ICIs \[1\]. The GM would be able to produce several molecules that can influence the growth of cancer cells and modulate anti-cancer immunity. Our project aims to investigate changes in the subject and its relationship to immunotherapy. Dynamic changes in cytokines can be a indicator of increased or decreased toxin translocation bacterial and therefore of the greater or lesser integrity of the barrier intestinal. Define the influence of diet on changes in GM can also help us understand how to modify these factors to improve the outcome of the subject undergoing immunotherapy.
Trial Details
NCT Number NCT07236983
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions Solid Tumor Cancer Treatment With Immunotherapy
Enrollment 70 participants
Start Date 2023-07-27
Primary Completion 2025-08-31 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-11-19