Clinical trial NCT05448222: Effect of Sarcopenia on Hepatocellular Carcinoma(HCC) After Systemic Therapies
Official title: Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Systemic Therapies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma
Sarcopenia
Keywords: hepatocellular carcinoma
sarcopenia
prognosis
adverse events
systemic therapy
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: 2022-07-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical diagnosis of hepatocellular carcinoma admitted to the first affiliated hospital of wenzhou medical university 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 systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: complications
timeFrame: 3 months
measure: overall survival
timeFrame: 2 years
measure: progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Hospital stay
timeFrame: 3 months
measure: Hospital cost
timeFrame: 3 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Gang Chen
state: Zhejiang
Study officials:
References:
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.
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.
citation: 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.
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.
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.