NCT06008548

Brief Summary

The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic stratification strategies to guide therapeutic allocation; however, the current guidelines did not consider the simultaneous comparison of distinct therapies in similar populations. Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients allocated to different treatments.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,991

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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, 2010

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

11.1 years

First QC Date

April 2, 2023

Last Update Submit

August 22, 2023

Conditions

HCCTransarterial ChemoembolizationResection

Outcome Measures

Primary Outcomes (1)

  • overall survival

    Overall survival (OS) was defined as the time interval between initial TACE or LR and all-cause death. Patients who survived up to the last follow-up date

    5 years

Study Arms (2)

TACE group

Incorporated HCC patients underwent TACE therapy.

Procedure: TACE

Liver resection group

Incorporated HCC patients underwent liver resection therapy.

Interventions

TACEPROCEDURE
TACE group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was diagnosed based on either imaging or pathological results as previously described

You may qualify if:

  • Diagnosed with HCC
  • Receiving LR or TACE therapy
  • Complete clinical information
  • Preserved liver function (Child-Pugh Score \[CPS\] ≤ 7)
  • PS 0-1

You may not qualify if:

  • Vascular invasion or extrahepatic spread;
  • Ecompensated liver cirrhosis ;
  • Younger than 18 years;
  • Duration of follow-up of fewer than 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lei Liu, doctor

    Tangdu Hospital-Air Force Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2023

First Posted

August 23, 2023

Study Start

January 1, 2010

Primary Completion

January 30, 2021

Study Completion

October 1, 2021

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share