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Liver Transplantation for Unresectable GIST Liver Metastases (TRANSGIST)

Primary Purpose

Liver Diseases, Liver Cancer, Liver Metastases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Liver Transplantation
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases focused on measuring liver transplantation, gastrointestinal stromal tumor (GIST), Transplant Oncology, liver neoplasms, liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Felipe Alconchel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver Transplantation

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival
Survival
Graft Survival
Liver graft Survival

Secondary Outcome Measures

Relapse free survival
Disease free survival

Full Information

First Posted
March 23, 2021
Last Updated
February 24, 2022
Sponsor
Hospital Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT04825470
Brief Title
Liver Transplantation for Unresectable GIST Liver Metastases
Acronym
TRANSGIST
Official Title
Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Liver Transplantation for Unresectable GIST Liver Metastases

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Liver Cancer, Liver Metastases, Liver Neoplasms, Liver Mass, Liver Carcinoma, Liver Transplant; Complications, Liver Transplant Disorder, GIST, GIST, Malignant, Gastrointestinal Stromal Tumors, Gastrointestinal Stromal Tumor of Duodenum, Gastrointestinal Stromal Tumor of Rectum, Gastrointestinal Stromal Tumor of Other Sites, Gastrointestinal Stromal Tumor, Unspecified Site, Gastrointestinal Stromal Tumor of Stomach, Gastrointestinal Stromal Tumor of Esophagus (Disorder), Gastrointestinal Stromal Tumor by AJCC V8 Stage, Gastrointestinal Stromal Tumor, Malignant, Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract, Gastrointestinal Stromal Tumor of Small Intestine (Disorder), Gastrointestinal Stromal Tumor of Large Intestine (Disorder), Metastases to Liver, Metastatic Liver Cancer, Metastasis, Metastases, Liver Transplantation, Transplant Oncology
Keywords
liver transplantation, gastrointestinal stromal tumor (GIST), Transplant Oncology, liver neoplasms, liver metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liver Transplantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Liver Transplantation
Intervention Description
Liver Transplantation
Primary Outcome Measure Information:
Title
Overall Survival
Description
Survival
Time Frame
Through study completion, an average of 2 years
Title
Graft Survival
Description
Liver graft Survival
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Relapse free survival
Time Frame
Through study completion, an average of 2 years
Title
Disease free survival
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Felipe Alconchel
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Alconchel, MD, PhD
Phone
+34667524352
Email
felipe.alconchel@carm.es
First Name & Middle Initial & Last Name & Degree
Juan Ángel Fernández-Hernández, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pablo Ramírez, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jerónimo Martínez, MD, PhD
First Name & Middle Initial & Last Name & Degree
Francisco Sánchez-Bueno, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ricardo Robles, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34592432
Citation
Fernandez JA, Alconchel F, Gomez B, Martinez J, Ramirez P. Unresectable GIST liver metastases and liver transplantation: A review and theoretical basis for a new indication. Int J Surg. 2021 Oct;94:106126. doi: 10.1016/j.ijsu.2021.106126. Epub 2021 Sep 27.
Results Reference
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Liver Transplantation for Unresectable GIST Liver Metastases

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