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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Secondary Malignant Neoplasm of RetroperitoneumSecondary Malignant Neoplasm of PeritoneumPseudomyxoma 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.

Trial Locations (1)

44195

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

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER