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NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Solid Tumor Cancer Treatment With Immunotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, SC Oncologia

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Time frame: After 3 weeks, after 12 weeks, after 24 weeks and in the case of progression disease

Secondary outcomes

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

Time frame: From time 0, baseline (at the start of ICIs) to the occurrence of irAEs
The difference in the cytokine profile in the blood sample

Time frame: 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.

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

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, baseline body composition assessed through CT scan images analysis skeletal muscle (SM), SM index (SMI) defined by height-normalized SM, visceral adipose tissue (VAT), VAT index (VATI) defined by height-normalized VAT, subcutaneous adipose tissue (SAT), VAT-SAT ratio (VAT/SAT), intramuscular adipose tissue (IMAT)], difference in body composition from baseline to week 12, baseline diagnosis of sarcopenia [defined by the presence of both reduced handgrip strength (below 27 Kg in men and 16 Kg in female) and reduced SMI (using validated sex- and BMI-specific cutoffs)] and baseline NRS-2002 score. Report BMI in kg/m^2
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

Time frame: Baseline

Baseline body composition assessed through CT scan images analysis skeletal muscle (SM), SM index (SMI) defined by height-normalized SM, visceral adipose tissue (VAT), VAT index (VATI) defined by height-normalized VAT, subcutaneous adipose tissue (SAT), VAT-SAT ratio (VAT/SAT), intramuscular adipose tissue (IMAT)], difference in body composition from baseline to week 12.

Baseline diagnosis of sarcopenia [defined by the presence of both reduced handgrip strength (below 27 Kg in men and 16 Kg in female) and reduced SMI (using validated sex- and BMI-specific cutoffs)]. Report BMI in kg/m^2 IRAE is defined by the Common Terminology Criteria for Adverse Events, version 5.0. This grading system refers to the severity of the adverse event associatedwith cancer therapy as follows: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life threatening; and grade 5, death
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

Time frame: From baseline to week 12

Baseline body composition assessed through CT scan images analysis skeletal muscle (SM), SM index (SMI) defined by height-normalized SM, visceral adipose tissue (VAT), VAT index (VATI) defined by height-normalized VAT, subcutaneous adipose tissue (SAT), VAT-SAT ratio (VAT/SAT), intramuscular adipose tissue (IMAT)], difference in body composition from baseline to week 12. Report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: GM&ICI

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Nov 19, 2025
Registry last updated: Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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