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Liver Transplantation for Unresectable GIST Liver Metastases (TRANSGIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04825470
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Felipe Alconchel, Hospital Universitario Virgen de la Arrixaca

Study Description
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Brief Summary:
Liver Transplantation for Unresectable GIST Liver Metastases

Condition or disease Intervention/treatment Phase
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 Procedure: Liver Transplantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Liver Transplantation Procedure: Liver Transplantation
Liver Transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Through study completion, an average of 2 years ]
    Survival

  2. Graft Survival [ Time Frame: Through study completion, an average of 2 years ]
    Liver graft Survival


Secondary Outcome Measures :
  1. Relapse free survival [ Time Frame: Through study completion, an average of 2 years ]
  2. Disease free survival [ Time Frame: Through study completion, an average of 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825470


Locations
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Spain
Felipe Alconchel
Murcia, Spain, 30120
Contact: Felipe Alconchel, MD, PhD    +34667524352    felipe.alconchel@carm.es   
Principal Investigator: Juan Ángel Fernández-Hernández, MD, PhD         
Principal Investigator: Pablo Ramírez, MD, PhD         
Principal Investigator: Jerónimo Martínez, MD, PhD         
Principal Investigator: Francisco Sánchez-Bueno, MD, PhD         
Principal Investigator: Ricardo Robles, MD, PhD         
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
More Information
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Publications:

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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: April 1, 2021    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Felipe Alconchel, Hospital Universitario Virgen de la Arrixaca:
liver transplantation
gastrointestinal stromal tumor (GIST)
Transplant Oncology
liver neoplasms
liver metastases
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Gastrointestinal Stromal Tumors
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
 Gastrointestinal Diseases
Neoplasms, Glandular and Epithelial
Intestinal Neoplasms
Carcinoma, Hepatocellular
Liver Diseases
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Carcinoma
Intestinal Diseases
Rectal Diseases
Colonic Diseases