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Organ transplant may offer new hope for rare abdominal cancer patients

NCT ID NCT06084780

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests whether an intestinal or multivisceral transplant can help people with a rare abdominal cancer called pseudomyxoma peritonei (PMP) that cannot be removed by surgery. Twenty participants will receive the transplant and be followed for 12 months to see if they survive and how safe the procedure is. The goal is to control the disease, not to cure it, as lifelong anti-rejection medication is needed after transplant.

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 20 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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.

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: * Subjects must have histologically confirmed pseudomyxoma peritonei (PMP) * Both low-grade mucinous carcinoma peritonei (LMCP) or high-grade mucinous carcinoma (HMCP), with or without signet ring cells as well as primary or recurrent disease, will be eligible. * PMP disease does not have any extra-abdominal metastases, with the exception of pulmonary involvement (nodal, parenchymal, and pleural). * PMP disease is extensive and not amenable to operative management, with or without liver, pancreas, stomach, or abdominal wall involvement. * Definition of Non-Resectable Disease- * Non-resectable PMP disease will be defined as the presence of at least one of the following conditions: * 1\) Extensive small bowel serosa involvement, where it is not possible to preserve at least 1.5-2 m of small bowel * 2\) Extensive infiltration of the pancreatic surface * 3\) Mesenteric involvement causing retraction * 4\) Need for complete gastric resection * 5\) Urete1ic obstruction * 6\) Liver disease with no chance to achieve R0 resection with liver remnant volume \> 30% * 7\) Recurrent disease not amenable to further resection * Subjects do not have any other available curative treatment options. * Subjects can have previous abdominal operations, including CRS+HIPEC. * Age ≥ 18 and ≤ 75. * Pediatric participants were excluded as PMP is a disease that affects adults. Participants \> 75 years of age are excluded as they are beyond the commonly accepted transplantability criteria. * Performance status ECOG ≤ 1. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Subjects with peritoneal carcinomatous originating from an etiology other than PMP. * Subjects receiving any other investigational agents. * Subjects with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would either put participation at risk because of participation in the study, may influence the result of the study, or limit compliance with study requirements. * Pregnant women are excluded from this study because an intestinal transplant is a procedure that is not compatible with a viable pregnancy. * Subjects who are HIV-positive may be included in the study. HIV testing is required for the study as adequate HIV treatment is required prior to intestinal transplant due to the increased risk of infection following transplantation and treatment with immunosuppressive agents.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195, United States

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