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NCT04825470 Clinical Trial

Liver Transplantation for Unresectable GIST Liver Metastases

Liver Cancer Clinical Trial

— TRANSGIST  

Official title:
Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04825470
Other study ID # TRANSGIST
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2022
Est. completion date December 2025

Study information
Verified date February 2022
Source Hospital Universitario Virgen de la Arrixaca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Liver Transplantation for Unresectable GIST Liver Metastases

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Carcinoma, Hepatocellular
  • Colorectal Neoplasms
  • Disease
  • Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract
  • Gastrointestinal Stromal Tumor by AJCC V8 Stage
  • Gastrointestinal Stromal Tumor of Duodenum
  • Gastrointestinal Stromal Tumor of Esophagus (Disorder)
  • Gastrointestinal Stromal Tumor of Large Intestine (Disorder)
  • Gastrointestinal Stromal Tumor of Other Sites
  • Gastrointestinal Stromal Tumor of Rectum
  • Gastrointestinal Stromal Tumor of Small Intestine (Disorder)
  • Gastrointestinal Stromal Tumor of Stomach
  • Gastrointestinal Stromal Tumor, Malignant
  • Gastrointestinal Stromal Tumor, Unspecified Site
  • Gastrointestinal Stromal Tumors
  • GIST
  • GIST, Malignant
  • Liver Cancer
  • Liver Carcinoma
  • Liver Diseases
  • Liver Mass
  • Liver Metastases
  • Liver Neoplasms
  • Liver Transplant Disorder
  • Liver Transplant; Complications
  • Liver Transplantation
  • Metastases
  • Metastases to Liver
  • Metastasis
  • Metastatic Liver Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Transplant Oncology

Intervention

Procedure:
• Liver Transplantation
Liver Transplantation

Locations
Country Name City State
Spain Felipe Alconchel Murcia

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Fernández JÁ, Alconchel F, Gómez B, Martínez J, Ramírez 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival Survival Through study completion, an average of 2 years
Primary Graft Survival Liver graft Survival Through study completion, an average of 2 years
Secondary Relapse free survival Through study completion, an average of 2 years
Secondary Disease free survival Through study completion, an average of 2 years
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