Radioembolization for Hepatocellular Carcinoma With Portal Vein Tumoral Thrombosis

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771988
• Other study ID #: Y90-2-LT-15-01
• Status: Completed
• Start date: May 8, 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2020
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Thrombosis

Intervention

Radiation:
• yttrium-90 radioembolization
selective/superselective treatment using resin microspheres labeled with Yttrium-90

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

References & Publications (2)

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: 10.1159/000 — View 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 microsph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to radioembolization	The primary endpoint of this study was to assess the effect of radioembolization in HCC patients with PVTT	6 months
Secondary	Overall survival	The secondary endpoint was overall survival (OS)	5 years
Secondary	Progression-free survival	The secondary endpoint was progression-free survival (PFS)	5 years