Influence of Sarcopenia in Hepatocellular Carcinoma Patients

Not yet recruiting

• Conditions: Sarcopenia
• Interventions: Procedure: TACE; Drug: Sorafenib; Procedure: local ablation

• Registration Number: NCT06177496
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Study Start: 2024-02-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	TACE	HCC patients underwent TACE
Group C	Sorafenib	HCC patients received sorafenib
Group A	local ablation	HCC patients underwent local ablation

Primary Outcome Measures

Name	Time	Method
overall survival	for at least 1 year from the treatment	time from treatment till death or last contact

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	for at least 1 year from the treatment	time from HCC treatment to tumor progression (identified by imaging) or last contact
Recurrence-free survival	for at least 1 year from the treatment	time from HCC treatment to tumor relapse (identified by imaging) or last contact