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Gut bacteria could be key to better cancer immunotherapy

NCT ID NCT07236983

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how the diversity of bacteria in the gut might affect how well immunotherapy works in people with solid tumors. Researchers will collect stool and blood samples from 70 cancer patients starting immunotherapy to track changes in gut bacteria and immune markers. They also want to see if diet, especially a Mediterranean diet, plays a role. The goal is to better understand why some patients respond to immunotherapy while others do not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify ways to improve immunotherapy effectiveness by modifying gut bacteria through diet or other means.
What could go wrong
This is an early observational study with only 70 participants, so results may not apply to all patients. It looks at patterns, not direct treatment effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor cancer treatment with immunotherapy

Contacts and locations

Locations

  • Fondazione IRCCS Policlinico San Matteo, SC Oncologia

    Pavia, Pavia, 27100, Italy

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