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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05443230
• Other study ID #: sarcopenia and prognosis
• Status: Enrolling by invitation
• Start date: June 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
China	Gang Chen	Wenzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University	Eastern Hepatobiliary Surgery Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Arulananda S, Segelov E. Sarcopenia and cancer-related inflammation measurements in advanced gastric and junctional cancers-ready for prime time? Ann Oncol. 2022 Jul;33(7):669-671. doi: 10.1016/j.annonc.2022.04.008. Epub 2022 Apr 14. No abstract available. — View Citation

Hanna L, Nguo K, Furness K, Porter J, Huggins CE. Association between skeletal muscle mass and quality of life in adults with cancer: a systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):839-857. doi: 10.1002/jcsm.12928. Epub 2022 Feb 13. — View Citation

Voron T, Tselikas L, Pietrasz D, Pigneur F, Laurent A, Compagnon P, Salloum C, Luciani A, Azoulay D. Sarcopenia Impacts on Short- and Long-term Results of Hepatectomy for Hepatocellular Carcinoma. Ann Surg. 2015 Jun;261(6):1173-83. doi: 10.1097/SLA.0000000000000743. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term results	Post-treatment complications	3 months
Primary	Long-term results	Overall survival; Progression free survival	2 years