Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

N/ACompletedNCT04771988

IRCCS Azienda Ospedaliero-Universitaria di Bologna17 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

yttrium-90 radioembolizationRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Response to radioembolization

The primary endpoint of this study was to assess the effect of radioembolization in HCC patients with PVTT

Time frame: 6 months

Secondary Outcomes

Overall survival

The secondary endpoint was overall survival (OS)

Time frame: 5 years

Progression-free survival

The secondary endpoint was progression-free survival (PFS)

Time frame: 5 years