Sarcopenia and Systemic Therapy in HCC

Prognostic Model of Survival of Patients With Hepatocarcinoma and Sarcopenia Treated With Systemic Therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06805552

Acronym

Sarco HCC

Enrollment

270

Registered

2025-02-03

Start date

2022-10-19

Completion date

2025-11-01

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC - Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Sarcopenia, HCC systemic therapy

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prognostic role of Sarcopenia in HCC patient's survival	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.

Secondary

Measure	Time frame	Description
Role of Sarcopenia in HCC systemic therapy tolerability	From January 2008 to April 2021	Evaluation of the role of sarcopenia on the duration and tolerability of systemic treatment in patients affected by HCC in liver cirrhosis.

Countries

Italy

Contacts

Primary ContactDr. Maurizio Biselli Principal Investigator, MD

maurizio.biselli@unibo.it+39 051 2142928

Outcome results