Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Gut bacteria boost? new trial tests probiotics to help immunotherapy fight stubborn colorectal cancer

NCT ID NCT06865521

Disease control Sponsor: West China Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether adding Akkermansia probiotics to standard immunotherapy and chemotherapy can safely help patients with advanced colorectal cancer that hasn't responded to prior treatments. The trial enrolls 22 adults whose tumors are MSS/pMMR type, which typically don't respond well to immunotherapy alone. Researchers will monitor side effects and measure tumor shrinkage, as well as changes in gut bacteria.

What this could mean

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

Active substance
Akkermansia probiotics (Songke) combined with anti-PD-1 monoclonal antibody and standard treatments (chemotherapy, TKI, or bevacizumab)
What this could lead to
If it works, this could point toward a way to make immunotherapy more effective for hard-to-treat colorectal cancers.
What could go wrong
This is a very early, small (22 people) single-center trial with no control group. The probiotics may not improve outcomes, and side effects from the combination are unknown.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 22 people

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

Started

Feb 2025

Expected to finish

Mar 2027

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.

Ages

18 to 75 years

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: * • Age 18-75 years * ECOG performance status score of 0-2 * Histopathologically confirmed colorectal cancer; tumor tissue immunohistochemistry or genetic testing showing pMMR or MSS/MSI-L type * Metastatic colorectal adenocarcinoma that has failed standard treatments (including irinotecan, oxaliplatin, fluorouracil, bevacizumab, cetuximab, etc.) * No prior use of immunotherapy (such as immune checkpoint inhibitors, adoptive cell immunotherapy, etc.) * At least one evaluable lesion according to RECIST version 1.1 criteria * No intestinal obstruction and good oral compliance * Adequate bone marrow, liver, and kidney function to receive treatment * Signed informed consent Exclusion Criteria: * • History of allergic diseases, severe drug allergies, or known allergies to probiotic drugs * Use of antibiotics or probiotic drugs/health products within the last 3 months * History of other malignancies with a disease-free interval of less than 5 years (except for cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors cured by endoscopic mucosal resection) * Presence of any active autoimmune disease or history of autoimmune disease * Current use of immunosuppressants or hormone therapy, continued within 2 weeks prior to enrollment * Concurrent severe infections * Congenital or acquired immune deficiency, or active hepatitis * Concurrent severe complications

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Akkermansia muciniphila are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal adenocarcinoma colorectal cancer

As listed by the trial registrant

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

Akkermansia muciniphila Colo-rectal cancer PD-1 inhibitor

Contacts and locations

Locations

  • Colorectal Cancer, West China Hospital

    Chengdu, Sichuan, 610041, China

  • Colorectal Cancer, West China Hospital

    Chengdu, Sichuan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.