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Clinical Trials in Italy / NCT07236983
Active, not recruiting Observational

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

NCT07236983 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Observational
Started
2023-07-27
Last updated
2025-11-19

Condition(s) studied

Solid Tumor Cancer Treatment With Immunotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged ≥18 years 2. Life-expectancy ≥6 months; 3. All participants have signed the consent form before enrollment 4. Patients with cancer who have to start immunotherapy with or without chemotherapy/targeted therapy Exclusion Criteria: 1. Patients reporting an intake of antibiotic therapy during the last 30 days (rifaximin therapy used in patients with hepatocellular carcinoma in order to decrease the occurrence of overt Hepatic Encephalopathy is permitted) or any probiotic therapy in the last 30 days 2. A personal history of autoimmune or inflammatory bowel disease 3. Any major intestinal surgery (including bariatric surgery) in the previous six months 4. Ongoing enteral or parenteral nutrition 5. Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcome measure(s)

  • The difference in alfa and beta diversity of GM in the stool sample — After 3 weeks, after 12 weeks, after 24 weeks and in the case of progression disease

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo, SC Oncologia Pavia Pavia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07236983 on ClinicalTrials.gov ↗ ← All trials in Italy