Radioembolization for Hepatocellular Carcinoma With 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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Yttrium-90 radioembolization

Radiation

selective/superselective treatment using resin microspheres labeled with Yttrium-90

Primary outcomes

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

Secondary outcomes

Overall survival

Time frame: 5 years

The secondary endpoint was overall survival (OS)
Progression-free survival

Time frame: 5 years

The secondary endpoint was progression-free survival (PFS)

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2020
First posted: Feb 25, 2021
Registry last updated: Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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