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Sarcopenia and Systemic Therapy in HCC (Sarco HCC)

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

HCC - Hepatocellular Carcinoma

Study type

Observational

Funder types

Other

Identifiers

NCT06805552
Sarco HCC

Details and patient eligibility

About

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.

Full 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.

Enrollment

270 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

270 participants in 1 patient group

HCC Patients
Description:
Patients with hepatocellular carcinoma treated with systemic therapy

Trial contacts and locations

1

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Central trial contact

Dr. Maurizio Biselli Principal Investigator, MD

Data sourced from clinicaltrials.gov

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