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

NCT05443230 | Unknown

• 1 other identifier: sarcopenia and prognosis
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Sarcopenia

Keywords

liver cancer; sarcopenia; lenvatinib; immune therapy; prognosis

Outcome Measures

Primary Outcomes (2)

• Short-term results

  Post-treatment complications

  3 months

• Long-term results

  Overall survival; Progression free survival

  2 years

Study Arms (2)

patients with sarcopenia

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

patients without sarcopenia

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

Interventions

gait speed; ct scan; grip strength and chair stand test DIAGNOSTIC_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 with sarcopenia; patients without sarcopenia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.

You may qualify if:

• Patients with clinical diagnosis of liver cancer
• No cancer other than liver cancer has been diagnosed
• Age ≥18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Gang Chen

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (3)

• 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.

  PMID: 35156342 BACKGROUND

• 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.

  PMID: 35430371 BACKGROUND

• 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.

  PMID: 24950264 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms; Sarcopenia

Interventions

Walking Speed; Tomography, X-Ray Computed; Hand Strength

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Muscle Strength

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)