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 | Active Not Recruiting

• 1 other identifier: GM&ICI
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• The difference in alfa and beta diversity of GM in the stool sample

  From time 0, baseline (at the start of ICIs) to the occurrence of irAEs

• The difference in the cytokine profile in the blood sample

  From time 0 baseline (at the start of ICIs) to the different time points (after 3 weeks, after 12 weeks, after 24 weeks and in the case of progression disease)

• The predictive factors associated with response to treatment with ICIs will be measured related to QueMD questionnaire score for adherence to Mediterranean diet at baseline, difference in QueMD questionnaire score from baseline to week 12.

  At the end of Cycle 3 or 4 (each cycle is 28 days)

• The predictive factors associated with development of irAEs will be measured related to QueMD questionnaire score at baseline, baseline body composition and sarcopenia diagnosis, and baseline NRS-2002 score

  Baseline

• Difference in body composition from baseline to week 12, related to the difference in alfa and beta diversity of GM in the stool sample from baseline to week 12

  From baseline to week 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with solid tumors who have to start immunotherapy are eligible. All types of cancer and all types of immunotherapy (anti CTLA-4/anti-PD-1/anti-PD-L1/a combination of anti-CTLA-4 and anti-PD1) with or without chemotherapy or target therapies are included. The estimated sample size is 100 cancer patients.

You may qualify if:

• Patients aged ≥18 years
• Life-expectancy ≥6 months;
• All participants have signed the consent form before enrollment
• Patients with cancer who have to start immunotherapy with or without chemotherapy/targeted therapy

You may not qualify if:

• 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
• A personal history of autoimmune or inflammatory bowel disease
• Any major intestinal surgery (including bariatric surgery) in the previous six months
• Ongoing enteral or parenteral nutrition
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC Oncologia

Pavia, Pavia, 27100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: November 19, 2025
• Study Start: July 27, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-02

Locations

IT (1)