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
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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

  1. Overall Survival [Through study completion, an average of 2 years]

    Survival

  2. Graft Survival [Through study completion, an average of 2 years]

    Liver graft Survival

Secondary Outcome Measures

  1. Relapse free survival [Through study completion, an average of 2 years]

  2. 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:

Study Results

No Results Posted as of Mar 11, 2022