Clinical trial NCT05443230: Effect of Sarcopenia on HCC After Lenvatinib and Anti-PD-1 Treatment
Official title: The Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Lenvatinib and Anti-PD-1 Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Cancer
Sarcopenia
Keywords: liver cancer
sarcopenia
lenvatinib
immune therapy
prognosis
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Eastern Hepatobiliary Surgery Hospital
name: Qilu Hospital of Shandong University
First posted: 2022-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Short-term results
timeFrame: 3 months
measure: Long-term results
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Gang Chen
state: Zhejiang
Study officials:
References:
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.
citation: 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.
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.