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

September 11, 2023 updated by: Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Gang Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 3 months
The complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.
3 months
overall survival
Time Frame: 2 years
Overall survival was defined as the time from initiation of lenvatinib to death for any reason.
2 years
progression free survival
Time Frame: 2 years
Progression free survival was defined as the time from initiation of lenvatinib to first progression or death.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 3 months
The time that patients spent in the hospital was recorded.
3 months
Hospital cost
Time Frame: 3 months
Hospital cost that patients spent was recorded.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

Qilu Hospital of Shandong University
Eastern Hepatobiliary Surgery Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sarcopenia and liver cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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