Status:
NOT_YET_RECRUITING
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Secondary Malignant Neoplasm of Retroperitoneum
Secondary Malignant Neoplasm of Peritoneum
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The goal of this prospective phase 2 study is to assess the efficacy and safety of intestinal or multivisceral transplantation for participants with PMP not amenable to other curative-intent treatment...
Detailed Description
Pseudomyxoma peritonei (PMP) is a rare clinical entity (approximately 2-4 cases per million people) characterized by extensive dissemination of mucinous ascites in the abdominal cavity. Relentless acc...
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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06084780
Start Date
December 1 2025
End Date
December 31 2025
Last Update
October 9 2025
Active Locations (1)
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1
Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195