Influence of Sarcopenia in Hepatocellular Carcinoma Patients

NCT06177496 | Unknown

• 1 other identifier: Soh-Med-23-09-11PD
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and quality of life for patients with unresectable HCC \[Couri and Pillai, 2019\]. However, curative therapies or locoregional therapies are not applicable to approximately 50% of HCC cases who are diagnosed at an advanced stage and have progression with transarterial therapies \[Park et al., 2015\]. For these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy \[Fan et al., 2022\]. Sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function \[Cruz-Jentoft and Sayer, 2019\]. It has been associated with higher mortality among the general population and patients with cancer. This study aims to assess the possible role of sarcopenia in predicting the outcome of HCC patients following a variety of treatments including local ablation, TACE and sorafenib.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• overall survival

  time from treatment till death or last contact

  for at least 1 year from the treatment

Secondary Outcomes (2)

• Recurrence-free survival

  for at least 1 year from the treatment

• Progression-free survival

  for at least 1 year from the treatment

Study Arms (3)

Group A

HCC patients underwent local ablation

Procedure: local ablation

Group B

HCC patients underwent TACE

Procedure: TACE

Group C

HCC patients received sorafenib

Drug: Sorafenib

Interventions

local ablation PROCEDURE

treatment of HCC

Group A

TACE PROCEDURE

treatment of HCC

Group B

Sorafenib DRUG

treatment of HCC

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment-naive hepatocellular carcinoma patients who underwent local ablation, TACE or sorafenib as a primary treatment.

You may qualify if:

• Clinical diagnosis of hepatocellular carcinoma.
• Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .

You may not qualify if:

• Use of other another HCC treatment modality e.g., resection.
• Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
• Patients with recurrent HCC.
• Patients with secondaries from extra-hepatic primary tumors.
• Incomplete data at the diagnosis, treatment or follow up time-points.
• Loss of patients follow up.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Sarcopenia

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 20, 2023
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12