Liver CancerNCT05443230
Effect of Sarcopenia on HCC After Lenvatinib and Anti-PD-1 Treatment
An observational study of Liver Cancer and Sarcopenia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 lenvatinib and anti-PD1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer, Sarcopenia
- What is being tested?
- gait speed; ct scan; grip strength and chair stand test
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.
Who may be able to join
- Patients with clinical diagnosis of liver cancer
- No cancer other than liver cancer has been diagnosed
- Age ≥18 years
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Lenvatinib and Anti-PD-1 Treatment
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.
Read the 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.
- Conditions
- Liver Cancer, Sarcopenia
- Being tested
- gait speed; ct scan; grip strength and chair stand test
- Keywords
- liver cancer, sarcopenia, lenvatinib, immune therapy, prognosis
- Medical subject headings
- Liver Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait speed; ct scan; grip strength and chair stand testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with sarcopenia | Not described Receives: Diagnostic Test: gait speed; ct scan; grip strength and chair stand test | |
| patients without sarcopenia | Not described Receives: Diagnostic Test: gait speed; ct scan; grip strength and chair stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term results
Post-treatment complications
Measured: 3 months
Long-term results
Overall survival; Progression free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhejiang Chinese Medical University, Eastern Hepatobiliary Surgery Hospital, Qilu Hospital of Shandong University
- Responsible party
- Principal investigator, Gang Chen, MD, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443230
- Sponsor's protocol ID
- sarcopenia and prognosis
- Status last verified
- Sep 2023
- First submitted
- 29 Jun 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanna L, Nguo K, Furness K, Porter J, Huggins CE. Association between skeletal muscle mass and quality of life in adults with cancer: a systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):839-857. doi: 10.1002/jcsm.12928. Epub 2022 Feb 13.
PubMed 35156342Arulananda S, Segelov E. Sarcopenia and cancer-related inflammation measurements in advanced gastric and junctional cancers-ready for prime time? Ann Oncol. 2022 Jul;33(7):669-671. doi: 10.1016/j.annonc.2022.04.008. Epub 2022 Apr 14. No abstract available.
PubMed 35430371Voron T, Tselikas L, Pietrasz D, Pigneur F, Laurent A, Compagnon P, Salloum C, Luciani A, Azoulay D. Sarcopenia Impacts on Short- and Long-term Results of Hepatectomy for Hepatocellular Carcinoma. Ann Surg. 2015 Jun;261(6):1173-83. doi: 10.1097/SLA.0000000000000743.
PubMed 24950264
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sarcopenia on the Efficacy and Prognosis of HCC Treated With Lenvatinib and Anti-PD-1 Treatment
- ClinicalTrials.gov ID
- NCT05443230
- Acronym / sponsor ID
- sarcopenia and prognosis
- Conditions
- Liver Cancer, Sarcopenia
- Keywords
- liver cancer, sarcopenia, lenvatinib, immune therapy, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhejiang Chinese Medical University, Eastern Hepatobiliary Surgery Hospital, Qilu Hospital of Shandong University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with sarcopenia | – | Diagnostic Test: gait speed; ct scan; grip strength and chair stand test |
| patients without sarcopenia | – | Diagnostic Test: gait speed; ct scan; grip strength and chair stand test |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis of liver cancer admitted to the hepatobiliary surgery department and received standard tests and questionnaires.
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of liver cancer
- No cancer other than liver cancer has been diagnosed
- Age ≥18 years
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait speed; ct scan; grip strength and chair stand testThe 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. | Diagnostic test | patients with sarcopenia, patients without sarcopenia |
Primary outcome
Short-term results
Time frame: 3 months
Post-treatment complications
Long-term results
Time frame: 2 years
Overall survival; Progression free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 35156342Hanna L, Nguo K, Furness K, Porter J, Huggins CE. Association between skeletal muscle mass and quality of life in adults with cancer: a systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):839-857. doi: 10.1002/jcsm.12928. Epub 2022 Feb 13.
- Background: PubMed 35430371Arulananda S, Segelov E. Sarcopenia and cancer-related inflammation measurements in advanced gastric and junctional cancers-ready for prime time? Ann Oncol. 2022 Jul;33(7):669-671. doi: 10.1016/j.annonc.2022.04.008. Epub 2022 Apr 14. No abstract available.
- Background: PubMed 24950264Voron T, Tselikas L, Pietrasz D, Pigneur F, Laurent A, Compagnon P, Salloum C, Luciani A, Azoulay D. Sarcopenia Impacts on Short- and Long-term Results of Hepatectomy for Hepatocellular Carcinoma. Ann Surg. 2015 Jun;261(6):1173-83. doi: 10.1097/SLA.0000000000000743.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Sarcopenia, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term results (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05443230, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.