HCC - Hepatocellular CarcinomaSarco HCCNCT06805552
Sarcopenia and Systemic Therapy in HCC
An observational study of HCC - Hepatocellular Carcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is a multi-center, retrospective observational study in patients with liver cancer (HCC) to assess the impact of sarcopenia (muscle loss) on the prognosis, duration, and tolerance of systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2022to 1 Nov 2025
- 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 affected with Hepatocellular Carcinoma
Who may be able to join
- Patients aged ≥18 years.
- Diagnosis of hepatocellular carcinoma based on histological and/or radiological results as defined by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD). The staging of hepatocellular carcinoma was obtained through contrast-enhanced liver CT and/or MRI.
- Patients with advanced (BCLC-C) or intermediate (BCLC-B) stage hepatocellular carcinoma, or patients with early-stage (BCLC-A) hepatocellular carcinoma who have not responded to previous locoregional ablative treatments and/or liver resection.
- Treatment with TKIs according to the indications and prescription criteria defined by AIFA, with no requirement to reach a minimum treatment period.
- Availability of a CT scan performed within no more than 8 weeks prior to the start of TKI therapy.
- Obtaining written informed consent.
Who cannot join
- None
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 AOUBO Policlinico di S.Orsola
Bologna, 40138
Dr. Maurizio Biselli, MD, +39 051 2142928, maurizio.biselli@unibo.it
Dr. Lorenzo Lani, MD, lorenzo.lani@studio.unibo.it
About this study
Official title: Prognostic Model of Survival of Patients With Hepatocarcinoma and Sarcopenia Treated With Systemic Therapy
This is a multi-center, retrospective observational study in patients with liver cancer (HCC) to assess the impact of sarcopenia (muscle loss) on the prognosis, duration, and tolerance of systemic treatment.
Read the detailed description
The impact of sarcopenia will be assessed 12 months after the start of chemotherapy. Additionally, other factors affecting prognosis will be investigated to develop a specific predictive model for the risk of death at 12 months. Finally, an external validation of this predictive model for the risk of death will be carried out.
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Sarcopenia, HCC systemic therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCC Patients | Patients with hepatocellular carcinoma treated with systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic role of Sarcopenia in HCC patient's survival
Evaluation of the prognostic role of sarcopenia in the survival of patients affected by HCC in liver cirrhosis and candidates for systemic treatment. Possible development of a specific classification system for the risk of death.
Measured: From January 2008 to April 2021
Secondary outcomes (1)
Role of Sarcopenia in HCC systemic therapy tolerability
Evaluation of the role of sarcopenia on the duration and tolerability of systemic treatment in patients affected by HCC in liver cirrhosis.
Measured: From January 2008 to April 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start19 Oct 2022
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805552
- Sponsor's protocol ID
- Sarco HCC
- Acronym
- Sarco HCC
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Model of Survival of Patients With Hepatocarcinoma and Sarcopenia Treated With Systemic Therapy
- ClinicalTrials.gov ID
- NCT06805552
- Acronym / sponsor ID
- Sarco HCC / Sarco HCC
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Sarcopenia, HCC systemic therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 3 Feb 2025 (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 multi-center, retrospective observational study in patients with liver cancer (HCC) to assess the impact of sarcopenia (muscle loss) on the prognosis, duration, and tolerance of systemic treatment.
Detailed description
The impact of sarcopenia will be assessed 12 months after the start of chemotherapy. Additionally, other factors affecting prognosis will be investigated to develop a specific predictive model for the risk of death at 12 months. Finally, an external validation of this predictive model for the risk of death will be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC Patients | – | –Patients with hepatocellular carcinoma treated with systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected with Hepatocellular Carcinoma
Key inclusion criteria (6 listed)
- Patients aged ≥18 years.
- Diagnosis of hepatocellular carcinoma based on histological and/or radiological results as defined by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD). The staging of hepatocellular carcinoma was obtained through contrast-enhanced liver CT and/or MRI.
- Patients with advanced (BCLC-C) or intermediate (BCLC-B) stage hepatocellular carcinoma, or patients with early-stage (BCLC-A) hepatocellular carcinoma who have not responded to previous locoregional ablative treatments and/or liver resection.
- Treatment with TKIs according to the indications and prescription criteria defined by AIFA, with no requirement to reach a minimum treatment period.
- Availability of a CT scan performed within no more than 8 weeks prior to the start of TKI therapy.
Key exclusion criteria (1 listed)
- None
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
Prognostic role of Sarcopenia in HCC patient's survival
Time frame: From January 2008 to April 2021
Evaluation of the prognostic role of sarcopenia in the survival of patients affected by HCC in liver cirrhosis and candidates for systemic treatment. Possible development of a specific classification system for the risk of death.
1 secondary outcome
Role of Sarcopenia in HCC systemic therapy tolerability
Time frame: From January 2008 to April 2021
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 3 Feb 2025.
- 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.
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 HCC - Hepatocellular Carcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 6 inclusion and 1 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 3 Feb 2025. 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 Dr. Maurizio Biselli Principal Investigator, MD (+39 051 2142928, maurizio.biselli@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic role of Sarcopenia in HCC patient's survival (time frame: From January 2008 to April 2021). 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 3 Feb 2025.