Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT04771988

Collaborator

(none)

Enrollment

91.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Radiation: yttrium-90 radioembolization

Study Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 8, 2013

Actual Primary Completion Date :

May 8, 2017

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Response to radioembolization [6 months]
The primary endpoint of this study was to assess the effect of radioembolization in HCC patients with PVTT

Secondary Outcome Measures

Overall survival [5 years]
The secondary endpoint was overall survival (OS)
Progression-free survival [5 years]
The secondary endpoint was progression-free survival (PFS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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