Influence of Sarcopenia in Hepatocellular Carcinoma Patients

Sarcopenia Clinical Trial

Official title:

Influence of Sarcopenia on Mortality and Disease Progression in Hepatocellular Carcinoma Treated With Ablation, Embolization and Sorafenib

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177496
• Other study ID #: Soh-Med-23-09-11PD
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of hepatocellular carcinoma.

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

Exclusion Criteria:

1. Use of other another HCC treatment modality e.g., resection.

2. Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.

3. Patients with recurrent HCC.

4. Patients with secondaries from extra-hepatic primary tumors.

5. Incomplete data at the diagnosis, treatment or follow up time-points.

6. Loss of patients follow up.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Sarcopenia

Intervention

Procedure:
• local ablation
treatment of HCC
• TACE
treatment of HCC

Drug:
• Sorafenib
treatment of HCC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	time from treatment till death or last contact	for at least 1 year from the treatment
Secondary	Recurrence-free survival	time from HCC treatment to tumor relapse (identified by imaging) or last contact	for at least 1 year from the treatment
Secondary	Progression-free survival	time from HCC treatment to tumor progression (identified by imaging) or last contact	for at least 1 year from the treatment