Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

NCT ID: NCT04771988

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-08

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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yttrium-90 radioembolization

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Rita Golfieri

Chief of Radiology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rita golfieri, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria di Bologna

References

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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.

Reference Type RESULT
PMID: 23615394 (View on PubMed)

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.

Reference Type RESULT
PMID: 19766639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34351679 (View on PubMed)

Other Identifiers

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Y90-2-LT-15-01

Identifier Type: -

Identifier Source: org_study_id

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