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NCT Number: NCT06805552

Sarcopenia and Systemic Therapy in HCC

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.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma Atrophy Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Muscular Atrophy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOUBO Policlinico di S.Orsola

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Dr. Lorenzo Lani, MD

CONTACT

[email protected]

Dr. Lorenzo Lani, MD

SUB_INVESTIGATOR

Dr. Maurizio Biselli, MD

CONTACT

[email protected]

+39 051 2142928

Dr. Maurizio Biselli, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prognostic role of Sarcopenia in HCC patient's survival

    Time frame: 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 outcomes

  1. Role of Sarcopenia in HCC systemic therapy tolerability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Maurizio Biselli Principal Investigator, MD

CONTACT

[email protected]

+39 051 2142928

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Registry information

Official study title

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

Acronym: Sarco HCC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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