Stratification for F-L Therapy After LT

NCT ID: NCT06564103

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-05

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplantation Adjuvant FOLFOX Plus Lenvatinib Machine Learning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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adjuvant FOLFOX plus lenvatinib therapy group

No interventions assigned to this group

non-adjuvant therapy group

Intervention Type COMBINATION_PRODUCT

Interventions

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Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiao Xu

OTHER

Sponsor Role lead

Responsible Party

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Xiao Xu

Principal Investigator, Clinical Professor,PHD,MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CT2024-ZJU-OBS10

Identifier Type: -

Identifier Source: org_study_id

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