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

NCT06084780 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

PROCEDURE

Intestinal, Multivisceral or Modified Multivisceral Transplantation

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

DRUG

Alemtuzumab

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.

DRUG

Tacrolimus

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.

DRUG

Sirolimus

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.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084780 on ClinicalTrials.gov