Effect of Sarcopenia on Hepatocellular Carcinoma(HCC) After Systemic Therapies

Hepatocellular Carcinoma Clinical Trial

Official title:

Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Systemic Therapies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05448222
• Other study ID #: sarcopenia and liver cancer
• Status: Enrolling by invitation
• Start date: July 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 systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.

Description:

By tracking the short-term and long-term results of HCC patients treated with systemic therapy,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 treatments 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 EuropeanWorking Group on Sarcopenia in Older People(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 treatments was explored.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• 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:

• clinical diagnosis of hepatocellular carcinoma

• No cancer other than liver cancer has been diagnosed

• Age =18 years

• child-pugh score=7

Exclusion Criteria:

• uncompleted standard tests and questionnaires

• 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)

• lost follow-up

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Sarcopenia

Intervention

Diagnostic Test:
• 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 (5)

Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4. — View Citation

Dasarathy S, Merli M. Sarcopenia from mechanism to diagnosis and treatment in liver disease. J Hepatol. 2016 Dec;65(6):1232-1244. doi: 10.1016/j.jhep.2016.07.040. Epub 2016 Aug 8. — View Citation

Kobayashi A, Kaido T, Hamaguchi Y, Okumura S, Shirai H, Yao S, Kamo N, Yagi S, Taura K, Okajima H, Uemoto S. Impact of Sarcopenic Obesity on Outcomes in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma. Ann Surg. 2019 May;269(5):924-931. doi: 10.1097/SLA.0000000000002555. — View Citation

Leong DP, Teo KK, Rangarajan S, Lopez-Jaramillo P, Avezum A Jr, Orlandini A, Seron P, Ahmed SH, Rosengren A, Kelishadi R, Rahman O, Swaminathan S, Iqbal R, Gupta R, Lear SA, Oguz A, Yusoff K, Zatonska K, Chifamba J, Igumbor E, Mohan V, Anjana RM, Gu H, Li W, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 Jul 18;386(9990):266-73. doi: 10.1016/S0140-6736(14)62000-6. Epub 2015 May 13. — View Citation

Smith C, Woessner MN, Sim M, Levinger I. Sarcopenia definition: Does it really matter? Implications for resistance training. Ageing Res Rev. 2022 Jun;78:101617. doi: 10.1016/j.arr.2022.101617. Epub 2022 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications	The complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.	3 months
Primary	overall survival	Overall survival was defined as the time from initiation of lenvatinib to death for any reason.	2 years
Primary	progression free survival	Progression free survival was defined as the time from initiation of lenvatinib to first progression or death.	2 years
Secondary	Hospital stay	The time that patients spent in the hospital was recorded.	3 months
Secondary	Hospital cost	Hospital cost that patients spent was recorded.	3 months