Effect of Sarcopenia on HCC After Lenvatinib and Anti-PD-1 Treatment

• Conditions: Liver Cancer; Sarcopenia
• Interventions: Diagnostic Test: gait speed; ct scan; grip strength and chair stand test

• Registration Number: NCT05443230
• 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 lenvatinib and anti-PD1.

Detailed Description

By tracking the short-term and long-term results of HCC patients treated with lenvatinib and anti-PD1,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 treatment 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 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 treatment was explored.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• 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: 200

Inclusion Criteria

Patients with clinical diagnosis of liver cancer

• No cancer other than liver cancer has been diagnosed
• Age ≥18 years

Exclusion Criteria

• Patients who could not complete the standard tests and questionnaires
• Patients 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with sarcopenia	gait speed; ct scan; grip strength and chair stand test	-
patients without sarcopenia	gait speed; ct scan; grip strength and chair stand test	-

Primary Outcome Measures

Name	Time	Method
Short-term results	3 months	Post-treatment complications
Long-term results	2 years	Overall survival; Progression free survival

Trial Locations

Locations (1)

Gang Chen; 🇨🇳 Wenzhou, Zhejiang, China