Hepatocellular CarcinomaNCT06018857
Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation
An observational study of Hepatocellular Carcinoma, run by Federico Aucejo at 2 sites in United States.
Trial summary
This is a registry study examining patients with HCC undergoing liver transplantation including outcomes and predictors of recurrence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2017to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients (age>18 years) undergoing Liver transplant for hepatocellular carcinoma
Who may be able to join
- Adult patients (age>18 years) undergoing Liver transplant for hepatocellular carcinoma
Who cannot join
- Patients under 18 years old
- Patients who do not have hepatocellular carcinoma
- patients who have hepatocellular carcinoma but do not undergo liver transplantation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
About this study
This is a registry study examining patients with HCC undergoing liver transplantation including outcomes and predictors of recurrence
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
Measured: From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.
Overall Survival
Measured: From date of surgery to date of death, up to 10 years after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start11 May 2017
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (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 Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico Aucejo
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor-investigator, Federico Aucejo, The Cleveland Clinic
- Investigators
- Federico Aucejo, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018857
- Sponsor's protocol ID
- 17-009
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wehrle CJ, Raj R, Maspero M, Satish S, Eghtesad B, Pita A, Kim J, Khalil M, Calderon E, Orabi D, Zervos B, Modaresi Esfeh J, Whitsett Linganna M, Diago-Uso T, Fujiki M, Quintini C, Kwon CD, Miller C, Pinna A, Aucejo F, Hashimoto K, Schlegel A. Risk assessment in liver transplantation for hepatocellular carcinoma: long-term follow-up of a two-centre experience. Int J Surg. 2024 May 1;110(5):2818-2831. doi: 10.1097/JS9.0000000000001104.
PubMed 38241354
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT06018857
- Acronym / sponsor ID
- 17-009
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Federico AucejoUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 11 May 2017 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Aug 2023 (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.
This is a registry study examining patients with HCC undergoing liver transplantation including outcomes and predictors of recurrence
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age>18 years) undergoing Liver transplant for hepatocellular carcinoma
Key inclusion criteria (1 listed)
- Adult patients (age>18 years) undergoing Liver transplant for hepatocellular carcinoma
Key exclusion criteria (3 listed)
- Patients under 18 years old
- Patients who do not have hepatocellular carcinoma
- patients who have hepatocellular carcinoma but do not undergo liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence Free Survival
Time frame: From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.
Overall Survival
Time frame: From date of surgery to date of death, up to 10 years after the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 38241354Wehrle CJ, Raj R, Maspero M, Satish S, Eghtesad B, Pita A, Kim J, Khalil M, Calderon E, Orabi D, Zervos B, Modaresi Esfeh J, Whitsett Linganna M, Diago-Uso T, Fujiki M, Quintini C, Kwon CD, Miller C, Pinna A, Aucejo F, Hashimoto K, Schlegel A. Risk assessment in liver transplantation for hepatocellular carcinoma: long-term follow-up of a two-centre experience. Int J Surg. 2024 May 1;110(5):2818-2831. doi: 10.1097/JS9.0000000000001104.
- Individual participant dataSharing planned: No
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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.
Federico Aucejo, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Federico Aucejo at 2 sites in United States.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival (time frame: From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.). 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 NCT06018857, 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 6 Mar 2026; AzTrials last refreshed its copy on 3 Nov 2026.