Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation

The Value of Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation

To investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase inhibitor in liver transplantation. Patients are enrolled into two groups according to the downstaging therapy they undergo before transplantion.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation
• Intervention / Treatment: Combination product: PVHA or TACE

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

(1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes. Patients who underwent resection, LT, or any form of downstaging treatment prior to enrollment were excluded.

Description

(1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment for downstaging purposes.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PVHA; Patients undergo tumor feeding vessels deprivation	Combination product: PVHA or TACE; PVHA or TACE
TACE; Patients undergo TACE therapy	Combination product: PVHA or TACE; PVHA or TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Underwent LT	Underwent LT	January 2013 and December 2020
Successful downstaging	Successful downstaging	January 2013 and December 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AFP reduction of patients	AFP reduction of patients	January 2013 and December 2020
Survival time of patients	Survival time of patients	January 2013 and December 2020
Recurrence of patients	Recurrence of patients	January 2013 and December 2020

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SHLTQC-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No