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Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

This study is testing a new approach for people with pseudomyxoma peritonei (PMP), a rare cancer that spreads in the abdomen, when other treatments haven't worked. It involves intestinal or multivisceral transplantation, which means receiving a donor intestine or multiple organs. After the transplant, you would receive medications like Alemtuzumab, Tacrolimus, and Sirolimus to help prevent your body from rejecting the new organs. The study aims to see how well these transplants help people survive for at least 12 months. People aged 18 to 75 with confirmed PMP, whether low-grade or high-grade, can join. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is designed to assess the efficacy and safety of transplantation.
What's involved
Participants will be placed on a transplant waiting list within one month of joining. After transplantation, you will receive specific medications and be followed for 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after surgery to assess survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06084780

Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

Not Yet Recruiting
PHASE2Ages 18–75InterventionalTreatment
Case Comprehensive Cancer Center
~20 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Intestinal, Multivisceral or Modified Multivisceral TransplantationAlemtuzumabTacrolimusSirolimus

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Rate of Survival
Measured over 12 months post operative

Conditions

Secondary Malignant Neoplasm of Retroperitoneum
Secondary Malignant Neoplasm of Peritoneum
Pseudomyxoma Peritonei

Explore related trials

Pseudomyxoma Peritonei

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Masato Fujiki, MD, PhD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Digestive Disease & Surgery Institute (DDSI) , Case Comprehensive Cancer Center

Who to contact

Masato Fujiki, MD, PhD
[email protected]
216-444-8007
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Overall Rate of Survival12 months post operative

    To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.