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Clinical Trials/NCT05443230
NCT05443230Enrolling By InvitationNot Applicable

The Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Lenvatinib and Anti-PD-1 Treatment

First Affiliated Hospital of Wenzhou Medical University1 site in 1 country200 target enrollmentStarted: June 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
200
Locations
1
Primary Endpoint
Short-term results

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Short-term results

Time Frame: 3 months

Post-treatment complications

Long-term results

Time Frame: 2 years

Overall survival; Progression free survival

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gang Chen, MD

Clinical Professor, Principal Investigator

First Affiliated Hospital of Wenzhou Medical University

Study Sites (1)

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