Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

February 24, 2021 updated by: Rita Golfieri, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Trans-arterial Radioembolization in Patients With Hepatocellular Carcinoma and Portal Vein Tumoral Thrombosis

In patients with hgepatocellular carcinoma (HCC) and portal vein tumoral thrombosis (PVTT), Sorafenib represents the treatment of choice but more recently, trans-arterial radioembolization (TARE) with yttrium-90 has been also proposed. A considerable percentage of such patients are not only able to achieve stability of the disease, but also to obtain a complete radiological response (CR). The possibility of achieving a CR might allow these patients to be listed for liver transplantation (LT), in order to cure not only the cancer but also the underlying cirrhosis that generated it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients diagnosed with HCC and PVTT presenting to our Institution

Description

Inclusion Criteria:

  1. diagnosis of HCC;
  2. age ≥ 18 years;
  3. performance status according to Eastern Cooperative Oncology Group 0-1;
  4. preserved liver function (Child-Pugh score ≤B7);
  5. PVTT limited to the first order portal branch.

Exclusion Criteria:

  1. any contraindication to TARE treatment;
  2. macrovascular invasion extended to the main portal trunk and/or to the contralateral portal branch;
  3. presence of extra-hepatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to radioembolization
Time Frame: 6 months
The primary endpoint of this study was to assess the effect of radioembolization in HCC patients with PVTT
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
The secondary endpoint was overall survival (OS)
5 years
Progression-free survival
Time Frame: 5 years
The secondary endpoint was progression-free survival (PFS)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: rita golfieri, MD, Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2013

Primary Completion (Actual)

May 8, 2017

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y90-2-LT-15-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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