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Could a constipation drug help keep colorectal cancer at bay?

NCT ID NCT07405736

Disease control Sponsor: Sun Yat-sen University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether adding lubiprostone, a drug usually used for constipation, to standard maintenance therapy can delay cancer recurrence in adults with colorectal cancer that has spread to the lining of the abdomen. About 124 participants who have had surgery will be randomly assigned to receive either maintenance therapy alone or with lubiprostone. The study aims to see if the combination improves progression-free survival at one year.

What this could mean

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

Active substance
lubiprostone
What this could lead to
If it works, this could point toward a new way to delay cancer recurrence in patients with peritoneal metastatic colorectal cancer.
What could go wrong
This is an early phase II trial with only 124 participants, so results may not apply broadly. Lubiprostone is typically used for constipation, and its long-term safety for cancer patients is still being studied.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 124 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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: * Voluntarily participates and provides written informed consent. * Histologically confirmed colon/rectal adenocarcinoma with molecular status confirmed as pMMR or MSS. * Cytoreductive surgery (CRS) achieves CC0/CC1 cytoreduction. * No extraperitoneal metastasis prior to treatment. * ECOG performance status 0-1 with adequate organ function per protocol requirements. Exclusion Criteria: * Extensive multisystem metastases on baseline imaging assessment. * Tumor carrying BRAF V600E mutation. * dMMR/MSI-H, or confirmed pathogenic POLE/POLD1 mutation(s). * Cachexia or decompensated organ dysfunction. * History of another malignancy within the past 5 years. * Known or suspected hypersensitivity/allergy to the study drug or related formulations. * Multiple primary cancers. * Any serious disease or other medical, psychological, or social condition that, in the investigator's judgment, may compromise participant safety or affect study results.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm neoplasm Neoplasm Metastasis peritoneal carcinomatosis peritoneum cancer

As listed by the trial registrant

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

Colorectal cancer (CRC) Colorectal cancer metastatic MSS metastatic colorectal cancer Peritoneal (metastatic) cancer Peritoneal metastasis

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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