Liver DiseasesTRANSGISTNCT04825470
Liver Transplantation for Unresectable GIST Liver Metastases
A study testing Liver Transplantation in people with Liver Diseases and Liver Cancer, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Liver Transplantation for Unresectable GIST Liver Metastases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Liver Cancer, Liver Metastases
- What is being tested?
- Liver Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- May 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Felipe Alconchel
Murcia, 30120
Felipe Alconchel, MD, PhD, +34667524352, felipe.alconchel@carm.es
Juan Ángel Fernández-Hernández, MD, PhD
About this study
Official title: Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases
Liver Transplantation for Unresectable GIST Liver Metastases
- Conditions
- Liver Diseases, Liver Cancer, Liver Metastases, Liver Neoplasms, Liver Mass, Liver Carcinoma
- Being tested
- Liver Transplantation
- Keywords
- liver transplantation, gastrointestinal stromal tumor (GIST), Transplant Oncology, liver neoplasms, liver metastases
- Medical subject headings
- Liver Diseases, Liver Neoplasms, Carcinoma, Hepatocellular, Gastrointestinal Stromal Tumors, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantationProcedure or surgery
Liver Transplantation
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplantation | Experimental | Not described Receives: Procedure: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Survival
Measured: Through study completion, an average of 2 years
Graft Survival
Liver graft Survival
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Relapse free survival
Measured: Through study completion, an average of 2 years
Disease free survival
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startMay 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Alconchel, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825470
- Sponsor's protocol ID
- TRANSGIST
- Acronym
- TRANSGIST
- Status last verified
- Feb 2022
- First submitted
- 23 Mar 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34592432
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases
- ClinicalTrials.gov ID
- NCT04825470
- Acronym / sponsor ID
- TRANSGIST / TRANSGIST
- Conditions
- Liver Diseases, Liver Cancer, Liver Metastases, Liver Neoplasms, Liver Mass, Liver Carcinoma
- Keywords
- liver transplantation, gastrointestinal stromal tumor (GIST), Transplant Oncology, liver neoplasms, liver metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liver Transplantation for Unresectable GIST Liver Metastases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplantation | Experimental | Procedure: Liver Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver TransplantationLiver Transplantation | Procedure or surgery | Liver Transplantation |
Primary outcome
Overall Survival
Time frame: Through study completion, an average of 2 years
Survival
Graft Survival
Time frame: Through study completion, an average of 2 years
Liver graft Survival
2 secondary outcomes
Relapse free survival
Time frame: Through study completion, an average of 2 years
Disease free survival
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 34592432Fernandez 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.
- Research RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Transplantation in people with Liver Diseases and Liver Cancer, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.