Impact of muscle loss on treatment outcomes in liver cancer
Prognostic Model of Survival of Patients With Hepatocarcinoma and Sarcopenia Treated With Systemic Therapy
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 |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06805552 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with hepatocellular carcinoma at various stages who are starting systemic therapy.
Not a fit: Patients with early-stage hepatocellular carcinoma who have not undergone prior treatments may not benefit from this study.
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 performed: Other studies have explored the relationship between sarcopenia and cancer outcomes, suggesting that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.