Liver Transplantation for Unresectable GIST Liver Metastases | NCT04825470

Studies
Liver Transplantation for Unresectable GIST Liver Metastases

NCT04825470

Sponsor

Hospital Universitario Virgen de la Arrixaca

Status

Unknown status

Last Update Posted

Mar 11, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

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

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2022Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2022

Last Update Posted Date

Mar 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Conditions Module

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

Keywords

liver transplantation
gastrointestinal stromal tumor (GIST)
Transplant Oncology
liver neoplasms
liver metastases

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Liver Transplantation	Experimental		Procedure: Liver Transplantation

Name	Type	Description	Arm Group Labels	Other Names
Liver Transplantation	Procedure	Liver Transplantation	Liver Transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Relapse free survival		Through study completion, an average of 2 years
Disease free survival		Through study completion, an average of 2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Felipe Alconchel		Murcia		30120	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34592432	Background	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.

ID	Term
D008107	Liver Diseases
D008113	Liver Neoplasms
D006528	Carcinoma, Hepatocellular
D046152	Gastrointestinal Stromal Tumors
D009362	Neoplasm Metastasis

ID	Term
D004066	Digestive System Diseases
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D005770	Gastrointestinal Neoplasms
D005767	Gastrointestinal Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D016377	Organ Transplantation
D014180	Transplantation