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Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04771988
Enrollment
17
Registered
2021-02-25
Start date
2013-05-08
Completion date
2020-12-31
Last updated
2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, macrovascular invasion, portal vein thrombosis

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.

Interventions

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

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Response to radioembolization6 monthsThe primary endpoint of this study was to assess the effect of radioembolization in HCC patients with PVTT

Secondary

MeasureTime frameDescription
Overall survival5 yearsThe secondary endpoint was overall survival (OS)
Progression-free survival5 yearsThe secondary endpoint was progression-free survival (PFS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026