Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

NCT04771988 | Completed

• 1 other identifier: Y90-2-LT-15-01
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; macrovascular invasion; portal vein thrombosis

Outcome Measures

Primary Outcomes (1)

• Response to radioembolization

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

  6 months

Secondary Outcomes (2)

• Overall survival

  5 years

• Progression-free survival

  5 years

Interventions

yttrium-90 radioembolization RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients diagnosed with HCC and PVTT presenting to our Institution

You may qualify if:

• diagnosis of HCC;
• age ≥ 18 years;
• performance status according to Eastern Cooperative Oncology Group 0-1;
• preserved liver function (Child-Pugh score ≤B7);
• PVTT limited to the first order portal branch.

You may not qualify if:

• any contraindication to TARE treatment;
• macrovascular invasion extended to the main portal trunk and/or to the contralateral portal branch;
• presence of extra-hepatic disease

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Related Publications (3)

• 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.

  PMID: 23615394 RESULT

• 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.

  PMID: 19766639 RESULT

• 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.

  PMID: 34351679 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• rita golfieri, MD

  Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Radiology Unit

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 25, 2021
• Study Start: May 8, 2013
• Primary Completion: May 8, 2017
• Study Completion: December 31, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02