Influence of Sarcopenia in Hepatocellular Carcinoma Patients

Sohag University

Status: Not yet enrolling

Conditions: Sarcopenia

Treatments: Procedure: local ablation; Drug: Sorafenib; Procedure: TACE

Study type: Observational

Funder types: Other

Identifiers

NCT06177496

Soh-Med-23-09-11PD

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 3 patient groups

Group A

Description:

HCC patients underwent local ablation

Treatment:

Procedure: local ablation

Group B

Description:

HCC patients underwent TACE

Treatment:

Procedure: TACE

Group C

Description:

HCC patients received sorafenib

Treatment:

Drug: Sorafenib