Organ transplant may offer new hope for rare abdominal cancer patients
NCT ID NCT06084780
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Keeping patients at the right temperature during surgery may protect their brain