Stratification for F-L Therapy After LT

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06564103

Enrollment

Registered

2024-08-21

Start date

2024-01-01

Completion date

2024-08-05

Last updated

2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvant FOLFOX Plus Lenvatinib, Liver Transplantation, Machine Learning

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
The disease-free survival rate was evaluated by follow-up investigation and outpatient review	1-5 years

Secondary

Measure	Time frame
The overall survival rate was evaluated by follow-up investigation and outpatient review	1-5 years

Countries

China

Outcome results