NCT05352204

Brief Summary

Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

April 22, 2022

Last Update Submit

February 11, 2023

Conditions

Carcinoma, Hepatocellular

Keywords

hepatocellular carcinomaTACEtumor necrosis

Outcome Measures

Primary Outcomes (1)

  • overall survival

    the number of months from the date of surgery to the date of the last follow-up visit or time of death.

    after liver resection until June 1, 2020

Secondary Outcomes (1)

  • disease-free survival

    after liver resection until June 1, 2020

Study Arms (2)

micronecrosis(+) group

Procedure: transcatheter arterial chemoembolization

micronecrosis(-) group

Interventions

transcatheter arterial chemoembolizationPROCEDURE

transcatheter arterial chemoembolization after liver resection

micronecrosis(+) group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From June 2014 to April 2018, HCC patients who underwent liver resection in our center were retrospectively reviewed.

You may qualify if:

  • (1) pathologically confirmed HCC (2) achievement of R0 resection.

You may not qualify if:

  • (1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FACS

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

April 30, 2020

Primary Completion

January 1, 2022

Study Completion

April 14, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

CN(2)