NCT05045573

Brief Summary

The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization. The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

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, 2014

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

7.6 years

First QC Date

September 6, 2021

Last Update Submit

September 29, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Pathological tumor response

    Patients are treated with SIRT, then if the tumor response was adequate, surgery was performed.Analysis after surgery. (6 months after SIRT)

    6 months

Secondary Outcomes (1)

  • Rate of Healthy liver hypertrophia

    day 1

Eligibility Criteria

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

aggressive hepatocellular carcinomas

You may qualify if:

  • \- aggressive hepatocellular carcinomas with vascular invasion, large tumors or multifocal distribution

You may not qualify if:

  • Other treatment after SIRT (confounding effect)
  • contraindications for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • Meerun MA, Allimant C, Riviere B, Herrero A, Panaro F, Assenat E, Cassinotto C, Mariano-Goulart D, Guiu B. Large, multifocal or portal vein-invading hepatocellular carcinoma (HCC) downstaged by Y90 using personalized dosimetry: safety, pathological results and outcomes after surgery. Hepatobiliary Surg Nutr. 2023 Jun 1;12(3):351-365. doi: 10.21037/hbsn-22-184. Epub 2022 Oct 31.

    PMID: 37351147DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • BORIS GUIU, PU-PH

    University Hospital, Montpellier

    STUDY DIRECTOR

  • Mohamad MEERUN, intern

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

January 1, 2014

Primary Completion

August 1, 2021

Study Completion

August 30, 2021

Last Updated

October 7, 2021

Record last verified: 2021-09

Locations

FR(1)