NCT05448339

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

11 years

First QC Date

June 29, 2022

Last Update Submit

January 7, 2024

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (2)

  • Underwent LT

    Underwent LT

    January 2013 and December 2020

  • Successful downstaging

    Successful downstaging

    January 2013 and December 2020

Secondary Outcomes (3)

  • AFP reduction of patients

    January 2013 and December 2020

  • Survival time of patients

    January 2013 and December 2020

  • Recurrence of patients

    January 2013 and December 2020

Study Arms (2)

PVHA

Patients undergo tumor feeding vessels deprivation

Combination Product: PVHA or TACE

TACE

Patients undergo TACE therapy

Combination Product: PVHA or TACE

Interventions

PVHA or TACECOMBINATION_PRODUCT

PVHA or TACE

PVHATACE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

(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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 7, 2022

Study Start

January 1, 2013

Primary Completion

December 31, 2023

Study Completion

January 1, 2024

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)