TRANSGIST: Liver Transplantation for Unresectable GIST Liver Metastases
Sponsor
Hospital Universitario Virgen de la Arrixaca (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04825470
Collaborator
(none)
50
1
1
43
1.2
Study Details
Study Description
Brief Summary
Liver Transplantation for Unresectable GIST Liver Metastases
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases
Anticipated Study Start Date
:
May 1, 2022
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2025
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Liver Transplantation
|
Procedure: Liver Transplantation
Liver Transplantation
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Through study completion, an average of 2 years]
Survival
- Graft Survival [Through study completion, an average of 2 years]
Liver graft Survival
Secondary Outcome Measures
- Relapse free survival [Through study completion, an average of 2 years]
- Disease free survival [Through study completion, an average of 2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
GIST diagnosis (c-Kit, CD34, DOG-1)
-
Imatinib-sensitive mutation
-
Non-resectable liver metastases
-
Abscence of extrahepatic disease
-
Period greater than two years between primary tumor and metastases diagnosis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Felipe Alconchel | Murcia | Spain | 30120 |
Sponsors and Collaborators
- Hospital Universitario Virgen de la Arrixaca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Felipe Alconchel,
MD, PhD, Principal Investigator,
Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT04825470
Other Study ID Numbers:
- TRANSGIST
First Posted:
Apr 1, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Felipe Alconchel,
MD, PhD, Principal Investigator,
Hospital Universitario Virgen de la Arrixaca
Additional relevant MeSH terms: