Impact of muscle loss on treatment outcomes in liver cancer
Official title: Prognostic Model of Survival of Patients With Hepatocarcinoma and Sarcopenia Treated With Systemic Therapy
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06805552 · Data updated 2026-11-12
This study looks at how losing muscle affects treatment results and survival in people with liver cancer over a year after starting chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | October 19, 2022 |
| Main results expected | November 1, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | February 3, 2025 |
| Trial ID | NCT06805552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with hepatocellular carcinoma at various stages who are starting systemic therapy.
✕Probably not a fit
Patients with early-stage hepatocellular carcinoma who have not undergone prior treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines patients with hepatocellular carcinoma (HCC) to evaluate how sarcopenia, or muscle loss, affects their prognosis, treatment duration, and tolerance to systemic therapies. The study will assess the impact of sarcopenia 12 months after the initiation of chemotherapy and will investigate additional factors influencing prognosis. A predictive model for the risk of death at 12 months will be developed and externally validated based on the findings.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with liver cancer by identifying those at higher risk due to muscle loss.
How similar studies have gone: Other studies have explored the relationship between sarcopenia and cancer outcomes, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * None
Where it's running
-
IRCCS AOUBO Policlinico di S.Orsola
Bologna, Italy Recruiting
Study contacts
- Study coordinator: Dr. Maurizio Biselli Principal Investigator, MD
- Email: maurizio.biselli@unibo.it
- Phone: +39 051 2142928
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.