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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05448222
Enrollment
300
Registered
2022-07-07
Start date
2022-07-01
Completion date
2024-12-01
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Sarcopenia

Keywords

hepatocellular carcinoma, sarcopenia, prognosis, adverse events, systemic therapy

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.

Interventions

DIAGNOSTIC_TESTDiagnostic 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.

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
CollaboratorOTHER
Eastern Hepatobiliary Surgery Hospital
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
First Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complications3 monthsThe complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.
overall survival2 yearsOverall survival was defined as the time from initiation of lenvatinib to death for any reason.
progression free survival2 yearsProgression free survival was defined as the time from initiation of lenvatinib to first progression or death.

Secondary

MeasureTime frameDescription
Hospital stay3 monthsThe time that patients spent in the hospital was recorded.
Hospital cost3 monthsHospital cost that patients spent was recorded.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026