Liver Transplantation for Unresectable GIST Liver Metastases

NCT04825470 — Not applicable, Unknown, 50 participants, Hospital Universitario Virgen de la Arrixaca

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

Registry	NCT04825470, acronym TRANSGIST
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	Hospital Universitario Virgen de la Arrixaca (Other)
Conditions	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
Interventions	Liver Transplantation (Procedure)
Dates	start 2022-05-01 (estimated), primary completion 2023-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2021-04-01, last updated 2022-03-11
Locations	1 site in Spain

-Summary

Liver Transplantation for Unresectable GIST Liver Metastases

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+Arms and interventions

Arm	Type	Interventions	Description
Liver Transplantation	Experimental	Procedure: Liver Transplantation

Liver Transplantation (Procedure): Liver Transplantation

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Felipe Alconchel	Murcia	Spain

+Publications

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. PMID 34592432