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

Sponsor

First Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05443230

Collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University (Other), Eastern Hepatobiliary Surgery Hospital (Other), Qilu Hospital of Shandong University (Other)

200

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer Sarcopenia	Diagnostic Test: gait speed; ct scan; grip strength and chair stand test

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Lenvatinib and Anti-PD-1 Treatment

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
patients with sarcopenia	Diagnostic Test: gait speed; ct scan; grip strength and chair stand test The chair stand test was administered, and the time required for the patient to stand five times from a sitting position without using the arms was measured. CT scan was to scan the patient's third lumbar level. For the gait speed test, the time that patients spent walking 8 meters on a flat indoor floor at usual walking speed was measured.Grip strength test:the dominant hand and the nondominant hand were measured twice intermittently (kg), and the average value of 4 values was obtained.
patients without sarcopenia	Diagnostic Test: gait speed; ct scan; grip strength and chair stand test The chair stand test was administered, and the time required for the patient to stand five times from a sitting position without using the arms was measured. CT scan was to scan the patient's third lumbar level. For the gait speed test, the time that patients spent walking 8 meters on a flat indoor floor at usual walking speed was measured.Grip strength test:the dominant hand and the nondominant hand were measured twice intermittently (kg), and the average value of 4 values was obtained.

Arm

Intervention/Treatment

patients with sarcopenia

Diagnostic Test: gait speed; ct scan; grip strength and chair stand test

The chair stand test was administered, and the time required for the patient to stand five times from a sitting position without using the arms was measured. CT scan was to scan the patient's third lumbar level. For the gait speed test, the time that patients spent walking 8 meters on a flat indoor floor at usual walking speed was measured.Grip strength test:the dominant hand and the nondominant hand were measured twice intermittently (kg), and the average value of 4 values was obtained.

patients without sarcopenia

Diagnostic Test: gait speed; ct scan; grip strength and chair stand test

Outcome Measures

Primary Outcome Measures

Short-term results [3 months]
Post-treatment complications
Long-term results [2 years]
Overall survival; Progression free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)