Stratification for F-L Therapy After LT
Stratification for Efficacy of Adjuvant FOLFOX Plus Lenvatinib After Liver Transplantation for Hepatocellular Carcinoma in Recurrence Prevention
Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy.
Methods: Liver recipients in the Shulan (Hangzhou) Hospital from January, 2017 to December, 2021, including 106 in the F-L therapy group and 229 in the non-adjuvant (N-A) therapy group were included in the analysis. A 1:1 propensity score matching (PSM) analysis was performed to minimize group imbalances. Disease-free survival (DFS) and overall survival (OS) were compared among recipients. Radiomics features that demonstrated predictive value for recurrence were employed, either independently or in conjunction with prognostic clinical features, to formulate predictive models. The combined model was used to perform further subgroup analysis for recipients in the F-L therapy group.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Zhejiang University school of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients fulfilling the Hangzhou criteria or exceeding the Hangzhou criteria with type 1 or 2 portal vein tumor thrombus (PVTT) before LT
Exclusion Criteria:
- 1) individuals less than 18 years old; 2) individuals with malignancies other than HCC; 3) individuals who survived less than 30 days after LT; and 4) individuals who lacked important prognostic variables, such as contrast-enhanced CT imaging information one month before transplantation, preoperative alpha-fetoprotein (AFP) levels, and tumor differentiation data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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adjuvant FOLFOX plus lenvatinib therapy group
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non-adjuvant therapy group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The disease-free survival rate was evaluated by follow-up investigation and outpatient review
Time Frame: 1-5 years
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1-5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The overall survival rate was evaluated by follow-up investigation and outpatient review
Time Frame: 1-5 years
|
1-5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CT2024-ZJU-OBS10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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