Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04771988
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-08
• Primary Completion: 2017-05-08
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival	5 years	The secondary endpoint was overall survival (OS)
Progression-free survival	5 years	The secondary endpoint was progression-free survival (PFS)