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CompletedNCT04771988Updated Feb 25, 2021

Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

An observational study in Hepatocellular Carcinoma, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • hepatocellular carcinoma
  • macrovascular invasion
  • portal vein thrombosis
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 17 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients diagnosed with HCC and PVTT presenting to our Institution

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Interventions

  • Radiationyttrium-90 radioembolization

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

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What researchers measure

Primary outcomes

  1. 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

  1. Overall survival

    The secondary endpoint was overall survival (OS)

    Time frame: 5 years

  2. Progression-free survival

    The secondary endpoint was progression-free survival (PFS)

    Time frame: 5 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Lau WY, Sangro B, Chen PJ, Cheng SQ, Chow P, Lee RC, Leung T, Han KH, Poon RT. Treatment for hepatocellular carcinoma with portal vein tumor thrombosis: the emerging role for radioembolization using yttrium-90. Oncology. 2013;84(5):311-8. doi: 10.1159/000348325. Epub 2013 Apr 18. PubMed 23615394 ↗
  • Salem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, Atassi B, Baker T, Gates V, Miller FH, Sato KT, Wang E, Gupta R, Benson AB, Newman SB, Omary RA, Abecassis M, Kulik L. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010 Jan;138(1):52-64. doi: 10.1053/j.gastro.2009.09.006. Epub 2009 Sep 18. PubMed 19766639 ↗
  • Barros N, Ermel A, Mihaylov P, Lacerda M, Fridell J, Kubal C. Deceased Donor Liver Transplantation from a SARS-CoV-2-Positive Donor to a SARS-CoV-2-Positive Recipient. Liver Transpl. 2021 Dec;27(12):1849-1851. doi: 10.1002/lt.26253. Epub 2021 Sep 17. No abstract available. PubMed 34351679 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04771988
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Rita Golfieri (Chief of Radiology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna) — Principal investigator
First posted
Feb 25, 2021
Start date
May 8, 2013
Primary completion
May 8, 2017
Completion
Dec 31, 2020
Last update
Feb 25, 2021

Study contacts

rita golfieri, MD
principal investigator · Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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