Clinical trial NCT04771988: Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis
Official title: Trans-arterial Radioembolization in Patients With Hepatocellular Carcinoma and Portal Vein Tumoral Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
macrovascular invasion
portal vein thrombosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with HCC and PVTT presenting to our Institution

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response to radioembolization
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Bologna
name: rita golfieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.