NCT04825470

Brief Summary

Liver Transplantation for Unresectable GIST Liver Metastases

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 11, 2022

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

March 23, 2021

Last Update Submit

February 24, 2022

Conditions

Liver DiseasesLiver CancerLiver MetastasesLiver NeoplasmsLiver MassLiver CarcinomaLiver Transplant; ComplicationsLiver Transplant DisorderGISTGIST, MalignantGastrointestinal Stromal TumorsGastrointestinal Stromal Tumor of DuodenumGastrointestinal Stromal Tumor of RectumGastrointestinal Stromal Tumor of Other SitesGastrointestinal Stromal Tumor, Unspecified SiteGastrointestinal Stromal Tumor of StomachGastrointestinal Stromal Tumor of Esophagus (Disorder)Gastrointestinal Stromal Tumor by AJCC V8 StageGastrointestinal Stromal Tumor, MalignantGastrointestinal Stromal Tumor (GIST) of the Gastrointestinal TractGastrointestinal Stromal Tumor of Small Intestine (Disorder)Gastrointestinal Stromal Tumor of Large Intestine (Disorder)Metastases to LiverMetastatic Liver CancerMetastasisMetastasesLiver TransplantationTransplant Oncology

Keywords

liver transplantationgastrointestinal stromal tumor (GIST)Transplant Oncologyliver neoplasmsliver metastases

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    Survival

    Through study completion, an average of 2 years

  • Graft Survival

    Liver graft Survival

    Through study completion, an average of 2 years

Secondary Outcomes (2)

  • Relapse free survival

    Through study completion, an average of 2 years

  • Disease free survival

    Through study completion, an average of 2 years

Study Arms (1)

Liver Transplantation

EXPERIMENTAL
Procedure: Liver Transplantation

Interventions

Liver TransplantationPROCEDURE

Liver Transplantation

Liver Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Felipe Alconchel

Murcia, 30120, Spain

Location

Related Publications (1)

  • 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: 34592432BACKGROUND

Related Links

MeSH Terms

Conditions

Liver DiseasesLiver NeoplasmsCarcinoma, HepatocellularGastrointestinal Stromal TumorsNeoplasm Metastasis

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueGastrointestinal NeoplasmsGastrointestinal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

April 1, 2021

Study Start

May 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2025

Last Updated

March 11, 2022

Record last verified: 2022-02

Locations

ES(1)