Stratification for F-L Therapy After LT

NCT06564103 | Completed DMC

• 1 other identifier: CT2024-ZJU-OBS10
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Adjuvant FOLFOX Plus Lenvatinib; Machine Learning

Outcome Measures

Primary Outcomes (1)

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

  1-5 years

Secondary Outcomes (1)

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

  1-5 years

Study Arms (2)

adjuvant FOLFOX plus lenvatinib therapy group

non-adjuvant therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients at Shulan (Hangzhou) Hospital from January 2017 to December 2021 were included in the analysis, which comprised 106 recipients in the F-L therapy group and 229 non-adjuvant (N-A) therapy group recipients.

You may qualify if:

• patients fulfilling the Hangzhou criteria or exceeding the Hangzhou criteria with type 1 or 2 portal vein tumor thrombus (PVTT) before LT

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Xiao Xu: lead

Study Sites (1)

Zhejiang University school of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor,PHD,MD

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 5, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)