Secondary Malignant Neoplasm of RetroperitoneumPhase 2TRANSCAPENCT06084780
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
A Phase 2 study testing Intestinal, Multivisceral or Modified Multivisceral Transplantation, Alemtuzumab and Tacrolimus in people with Secondary Malignant Neoplasm of Retroperitoneum and Secondary Malignant Neoplasm of Peritoneum, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum, Pseudomyxoma Peritonei
- What is being tested?
- Intestinal, Multivisceral or Modified Multivisceral Transplantation, Alemtuzumab and Tacrolimus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic Digestive Disease & Surgery Institute (DDSI), Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Masato Fujiki, MD, PhD, 216-444-8007, fujikim@ccf.org
About this study
Official title: Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
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.
Read the 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
- Being tested
- Intestinal, Multivisceral or Modified Multivisceral Transplantation, Alemtuzumab, Tacrolimus, Sirolimus
- Keywords
- Intestinal Transplantation, Multivisceral Transplantation, Pseudomyxoma Peritonei, Unresectable Mucinous Carcinoma Peritonei, TRANSCAPE
- Medical subject headings
- Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal, Multivisceral or Modified Multivisceral TransplantationProcedure or surgery
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
AlemtuzumabDrug
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.
TacrolimusDrug
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.
SirolimusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intestinal, Multivisceral or Modified Multivisceral Transplantation; Drug: Alemtuzumab; Drug: Tacrolimus; Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Rate of Survival
To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.
Measured: 12 months post operative
Secondary outcomes (3)
Overall Rate of Morbidity
Determine the morbidity of intestinal or multivisceral transplantation for participants with unresectable at 90 days by monitoring severe adverse events as classified according to Clavien-Dindo grade and comprehensive complication index.
Measured: 90 days post operative
Overall Rate of Morbidity
Determine the morbidity of intestinal or multivisceral transplantation for participants with unresectable at 12 months by monitoring severe adverse events as classified according to Clavien-Dindo grade and comprehensive complication index.
Measured: 12 months post operative
Overall Rate of Mortality
Determine cancer-related and transplant-related mortality after intestinal or multivisceral transplantation in participants with unresectable PMP.
Measured: 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startNov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignant Neoplasm of RetroperitoneumStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masato Fujiki, MD, PhD, Principal investigator, Cleveland Clinic Digestive Disease & Surgery Institute (DDSI) , Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084780
- Sponsor's protocol ID
- CASE7Z23
- Acronym
- TRANSCAPE
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As an investigator-initiated protocol, individual participant data will not need to be shared with any other third party. Reported results from this trial will be aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Series of Intestinal and Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
- ClinicalTrials.gov ID
- NCT06084780
- Acronym / sponsor ID
- TRANSCAPE / CASE7Z23
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intestinal, Multivisceral or Modified Multivisceral Transplantation | Experimental | Procedure: Intestinal, Multivisceral or Modified Multivisceral Transplantation, Drug: Alemtuzumab, Drug: Tacrolimus, Drug: SirolimusParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects must have histologically confirmed pseudomyxoma peritonei (PMP)
- 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.
- Subjects do not have any other available curative treatment options.
- Age ≥ 18 and ≤ 75.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal, Multivisceral or Modified Multivisceral TransplantationEnrolled 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 | Procedure or surgery | Intestinal, Multivisceral or Modified Multivisceral Transplantation |
| AlemtuzumabA 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 | Intestinal, Multivisceral or Modified Multivisceral Transplantation |
| TacrolimusA 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 | Intestinal, Multivisceral or Modified Multivisceral Transplantation |
| SirolimusA 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. | Drug | Intestinal, Multivisceral or Modified Multivisceral Transplantation |
Primary outcome
Overall Rate of Survival
Time frame: 12 months post operative
To determine overall 12-month survival after intestinal or multivisceral transplantation in participants with unresectable PMP.
3 secondary outcomes
Overall Rate of Morbidity
Time frame: 90 days post operative
Overall Rate of Morbidity
Time frame: 12 months post operative
Overall Rate of Mortality
Time frame: 12 months post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. As an investigator-initiated protocol, individual participant data will not need to be shared with any other third party. Reported results from this trial will be aggregated data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Masato Fujiki, MD, PhD principal investigator
Cleveland Clinic Digestive Disease & Surgery Institute (DDSI) , Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intestinal, Multivisceral or Modified Multivisceral Transplantation, Alemtuzumab and Tacrolimus in people with Secondary Malignant Neoplasm of Retroperitoneum and Secondary Malignant Neoplasm of Peritoneum, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Masato Fujiki, MD, PhD (216-444-8007, fujikim@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Rate of Survival (time frame: 12 months post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.