Solid Tumor Cancer Treatment With ImmunotherapyGM&ICINCT07236983
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
An observational study of Solid Tumor Cancer Treatment With Immunotherapy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer Treatment With Immunotherapy
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jul 2023to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC Oncologia
Pavia, Pavia, 27100
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in alfa and beta diversity of GM in the stool sample
Measured: 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
Measured: From time 0, baseline (at the start of ICIs) to the occurrence of irAEs
The difference in the cytokine profile in the blood sample
Measured: 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.
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
Measured: 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 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
Measured: 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
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
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start27 Jul 2023
- Primary completion31 Aug 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Cancer Treatment With ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236983
- Sponsor's protocol ID
- GM&ICI
- Acronym
- GM&ICI
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07236983
- Acronym / sponsor ID
- GM&ICI / GM&ICI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 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 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Cancer Treatment With Immunotherapy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.