NCT07236983

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor Cancer Treatment With Immunotherapy

Timeline

• Start date: 2023-07-27
• Primary completion: 2025-08-31
• Completion: 2026-08-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: Italy