Hepatocellular CarcinomaLEATUMNCT05714124
Liver Embolization Approaches for Tumor Management
An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Metastatic Colon Cancer
- What is being tested?
- Embolization
- Type of treatment
- Surgery or procedure
- How many people
- 580 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2021to 31 Dec 2031
- How long will I take part?
- 5 Years
- 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: Patients with primary or secondary liver tumors
Who may be able to join
- ≥ 18 yoa
- patients with patients with primary or secondary liver disease not amenable for surgery or ablation
- patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
- able and willing to sign informed consent
Who cannot join
- pregnant women
- patients with uncorrectable coagulopathy
- diffuse extrahepatic disease
- for lobar TACE and TARE - presence of bilodigestive shunt
- for TARE - >20% hepatopulmonary shunt
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Francesco De Cobelli, MD, +39022643 ext. 2529, trialcliniciradiologia@hsr.it
Stephanie Steidler, PhD, +39022643 ext. 6111, steidler.stephanie@hsr.it
About this study
Official title: Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms
The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma, Metastatic Colon Cancer, Metastatic Cancer, Metastatic Gastric Cancer, Primary Liver Cancer
- Being tested
- Embolization
- Keywords
- embolization, TAE, TACE, TARE, PVE, HVE
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Colonic Neoplasms, Neoplasm Metastasis, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbolizationProcedure or surgery
Also called Transarterial Chemoembolisation, Transarterial Radioembolization, Bland Transarterial Embolization, Hepatic Vein Embollization
Endovascular treatment for patients with primary and secondary liver tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Treatment Efficacy
Measured: Short term (3-6 months)
Progression free survival
Measured: From time of intervention up to 1 year (medium term)
Progression free survival
Measured: From time of intervention up to 5 years (Long term)
Residual hepatic volume
Treatment Efficacy
Measured: within 40 days of procedure
Secondary outcomes (1)
Overall survival
Overall survival
Measured: From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start21 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 580 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco De Cobelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714124
- Sponsor's protocol ID
- LEATUM
- Acronym
- LEATUM
- Status last verified
- Apr 2024
- First submitted
- 25 Jan 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms
- ClinicalTrials.gov ID
- NCT05714124
- Acronym / sponsor ID
- LEATUM / LEATUM
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma, Metastatic Colon Cancer, Metastatic Cancer, Metastatic Gastric Cancer, Primary Liver Cancer
- Keywords
- embolization, TAE, TACE, TARE, PVE, HVE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Feb 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.
The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or secondary liver tumors
Key inclusion criteria (4 listed)
- ≥ 18 yoa
- patients with patients with primary or secondary liver disease not amenable for surgery or ablation
- patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
- able and willing to sign informed consent
Key exclusion criteria (5 listed)
- pregnant women
- patients with uncorrectable coagulopathy
- diffuse extrahepatic disease
- for lobar TACE and TARE - presence of bilodigestive shunt
- for TARE - >20% hepatopulmonary shunt
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 |
|---|---|---|
| EmbolizationAlso: Transarterial Chemoembolisation, Transarterial Radioembolization, Bland Transarterial Embolization, Hepatic Vein EmbollizationEndovascular treatment for patients with primary and secondary liver tumors | Procedure or surgery | – |
Primary outcome
Progression free survival
Time frame: Short term (3-6 months)
Treatment Efficacy
Progression free survival
Time frame: From time of intervention up to 1 year (medium term)
Progression free survival
Time frame: From time of intervention up to 5 years (Long term)
Residual hepatic volume
Time frame: within 40 days of procedure
Treatment Efficacy
1 secondary outcome
Overall survival
Time frame: From date of procedure until the date of death from any cause, whichever came first, assessed up to 5 years
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 12 Apr 2024.
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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.
1 site 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 and Cholangiocarcinoma, run by IRCCS San Raffaele at 1 site in Italy.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Apr 2024. 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 Italy. 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?
Contact Francesco De Cobelli, MD (+39022643 ext. 2529, trialcliniciradiologia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Short term (3-6 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.