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

NCT06084780 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CASE7Z23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 treatments. Participants will undergo intestinal/multivisceral transplantation. Participants will be followed for 12 months to assess efficacy and safety.

Conditions

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

Keywords

Intestinal Transplantation; Multivisceral Transplantation; Pseudomyxoma Peritonei; Unresectable Mucinous Carcinoma Peritonei; TRANSCAPE

Outcome Measures

Primary Outcomes (1)

• Overall Rate of Survival

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

  12 months post operative

Secondary Outcomes (3)

• Overall Rate of Morbidity

  90 days post operative

• Overall Rate of Morbidity

  12 months post operative

• Overall Rate of Mortality

  12 months post operative

Study Arms (1)

Intestinal, Multivisceral or Modified Multivisceral Transplantation

EXPERIMENTAL

Participants will undergo intestinal or modified multivisceral transplantation according to their disease extent. Participants will be followed for 12 months from the day of transplantation. Participants will undergo routine clinical follow-up according to standard protocols for the management of participants after visceral organ transplantation and standard oncological follow-up for participants with PMP.

Procedure: Intestinal, Multivisceral or Modified Multivisceral Transplantation; Drug: Alemtuzumab; Drug: Tacrolimus; Drug: Sirolimus

Interventions

Alemtuzumab DRUG

A post-transplant, steroid-free immunosuppressive regimen will be utilized and will include Alemtuzumab as Antibody Induction Therapy. Participants will be administered two doses of Alemtuzumab (30 mg IV) on days 0 and 1.

Intestinal, Multivisceral or Modified Multivisceral Transplantation

Tacrolimus DRUG

A post-transplant, steroid-free immunosuppressive regimen will be utilized and will include Tacrolimus for maintenance. Participants will have Tacrolimus for the first 3 months. Dosing of Tacrolimus will depend on participant target level, starting with 0.05 mg/Kg bid.

Intestinal, Multivisceral or Modified Multivisceral Transplantation

Sirolimus DRUG

A post-transplant, steroid-free immunosuppressive regimen will be utilized and will include Sirolimus for maintenance. Participants will have Sirolimus after 3 months of Tacrolimus. Dosing of Sirolimus will depend on participant target level, starting with 2 mg od.

Intestinal, Multivisceral or Modified Multivisceral Transplantation

Intestinal, Multivisceral or Modified Multivisceral Transplantation PROCEDURE

Enrolled participants will enter the active transplant waiting list within one month of signing informed consent for study participation. Participants can be listed for: * Isolated small bowel transplant (SBT): transplantation of the donor small intestine * Modified multivisceral tran I lant (MMVT): transplantation of the donor pancreas and small intestine, with or without stomach * Multivisceral transplant (MVT): transplantation of the donor pancreas, small intestine, and liver, with or without stomach

Intestinal, Multivisceral or Modified Multivisceral Transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) Extensive small bowel serosa involvement, where it is not possible to preserve at least 1.5-2 m of small bowel
• \) Extensive infiltration of the pancreatic surface
• \) Mesenteric involvement causing retraction
• \) Need for complete gastric resection
• \) Urete1ic obstruction
• \) Liver disease with no chance to achieve R0 resection with liver remnant volume \> 30%
• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Interventions

Alemtuzumab; Tacrolimus; Sirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Masato Fujiki, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Masato Fujiki, MD, PhD

CONTACT

216-444-8007; fujikim@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)