Effect of Sarcopenia on Hepatocellular Carcinoma(HCC) After Systemic Therapies

• Conditions: Hepatocellular Carcinoma; Sarcopenia

• Registration Number: NCT05448222
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief Summary

Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.

Detailed Description

By tracking the short-term and long-term results of HCC patients treated with systemic therapy,the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after systemic treatments was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.All implementation details are based on the newest EuropeanWorking Group on Sarcopenia in Older People(EWGSOP) definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes, the differences were analyzed and the relationship between sarcopenia and prognosis of systemic treatments was explored.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• clinical diagnosis of hepatocellular carcinoma
• No cancer other than liver cancer has been diagnosed
• Age ≥18 years
• child-pugh score≤7

Exclusion Criteria

• uncompleted standard tests and questionnaires
• received other therapies
• Patients who had other causes of muscle weakness (injury, fracture, stroke, etc.)
• Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
• lost follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complications	3 months	The complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.
progression free survival	2 years	Progression free survival was defined as the time from initiation of lenvatinib to first progression or death.
overall survival	2 years	Overall survival was defined as the time from initiation of lenvatinib to death for any reason.

Secondary Outcome Measures

Name	Time	Method
Hospital cost	3 months	Hospital cost that patients spent was recorded.
Hospital stay	3 months	The time that patients spent in the hospital was recorded.

Trial Locations

Locations (1)

Gang Chen; 🇨🇳 Wenzhou, Zhejiang, China