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

NCT ID: NCT07236983

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Angioletta Lasagna

Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione IRCCS Policlinico San Matteo, SC Oncologia

Pavia, Pavia, Italy

Countries

Italy

Other Identifiers

GM&ICI

Identifier Type: -

Identifier Source: org_study_id