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Can a gut bacteria transplant help immunotherapy wipe out rectal cancer before surgery?

NCT ID NCT07738042

Disease control Sponsor: Tianjin Medical University Cancer Institute and 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial is testing whether transplanting healthy gut bacteria can boost the power of immunotherapy and chemoradiotherapy in people with a common type of locally advanced rectal cancer. Participants receive a combination of sintilimab (an immunotherapy drug), CAPOX chemotherapy, short-course radiation, and intestinal bacteria transplants before surgery. The main goal is to see if this combination can make the tumor completely disappear by the time of surgery.

What this could mean

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

Active substance
a combination of sintilimab (an immunotherapy drug), CAPOX chemotherapy (oxaliplatin and capecitabine), short-course radiotherapy, and intestinal bacteria transplantation
What this could lead to
If it works, this approach could increase the chance of a complete tumor disappearance before surgery, potentially allowing more patients to avoid permanent colostomy.
What could go wrong
This is an early-phase, single-arm trial with only 46 participants, so results may not apply broadly. The combination carries risks of immune-related side effects, infection from bacteria transplantation, and chemotherapy toxicity.

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 46 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: 1. ECOG PS 0-1 2. The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible 3. RAS/BRAF wild type, pMMR/MSS status 4. Patients of childbearing age need to take effective contraceptive measures. 5. Voluntarily sign the informed consent form Exclusion Criteria: 1. dMMR/MSI-H type 2. Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy); 3. Active autoimmune diseases, inflammatory bowel disease; 4. Active infection, immune deficiency, severe liver and kidney dysfunction; 5. Severe intestinal obstruction, perforation or requiring emergency surgery; 6. Pregnant or lactating women; 7. Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.); 8. Other circumstances where participation in clinical trials is not suitable

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Conditions

The condition(s) this trial relates to.

rectal cancer

As listed by the trial registrant

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

Locally advanced rectal cancer (LARC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, China

More trials for these conditions

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