NCT06084780

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

Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 accumulation of mucin causes progressive abdominal distention, intestinal obstruction, malnutrition, cachexia, and ultimately death. As a rare disease, diagnosis is often late, and usually occurs when the disease is in a clinically advanced stage. The prognosis of PMP has been dramatically improved by the introduction of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). While outcomes are favorable for participants with disease amenable to CRS+HIPEC, the therapeutic options for participants with unresectable PMP are limited. Intestinal transplantation represents a therapeutic option in participants with unresectable PMP. Overall survival has been shown to improve with participants with unresectable PMP during an Oxford Transplant Center study. The goal of this study is to corroborate the Oxford results on an American cohort.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-16
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study