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OpenTrials
Completed

NCT Number: NCT06564103

Stratification for F-L Therapy After LT

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.

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Key information

Conditions

Liver Transplantation Adjuvant FOLFOX Plus Lenvatinib Machine Learning

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang University school of Medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The disease-free survival rate was evaluated by follow-up investigation and outpatient review

    Time frame: 1-5 years

Secondary outcomes

  1. The overall survival rate was evaluated by follow-up investigation and outpatient review

    Time frame: 1-5 years

Sponsors and collaborators

Lead sponsor

Xiao Xu

Other

Registry information

Official study title

Stratification for Efficacy of Adjuvant FOLFOX Plus Lenvatinib After Liver Transplantation for Hepatocellular Carcinoma in Recurrence Prevention

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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