Sarcopenia and Systemic Therapy in HCC

IRCCS Azienda Ospedaliero-Universitaria di Bologna270 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

270

Conditions

HCC - Hepatocellular Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS AOUBO Policlinico di S.Orsola

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: From January 2008 to April 2021

Secondary Outcomes

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.

Time frame: From January 2008 to April 2021

Central Contacts

Dr. Maurizio Biselli Principal Investigator, MD

CONTACT

+39 051 2142928 maurizio.biselli@unibo.it

Data from ClinicalTrials.gov

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