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A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)


N/A
18 Years
N/A
Not Enrolling
Both
Unresectable Hepatocellular Carcinoma With Portal Vein Thrombosis

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Trial Information

A Prospective Randomized Clinical Trial on 90Yttrium Trans-arterial Radio-Embolization (TheraSphere®) vs. Standard of Care (Sorafenib) for the Treatment of Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Thrombosis (PVT)


The objective of this phase III, prospective randomized trial is to determine whether
TheraSphere provides a meaningful benefit in survival in comparison with the standard of
care (sorafenib) in patients with good hepatic function and advanced hepatocellular
carcinoma (HCC) associated with portal vein thrombosis (PVT).

This is an open-label prospective, multi-center, randomized, controlled clinical trial that
will evaluate the use of TheraSphere compared to standard-of-care sorafenib alone.


Inclusion Criteria:



- advanced unresectable hepatocellular carcinoma with portal vein thrombosis

- Child Pugh A

- ECOG <2

- unilobar disease

Exclusion Criteria:

- contraindication to study treatment or procedures

- eligible for curative treatment including liver transplant

- prior external beam radiation therapy

- prior treatment with sorafenib for more than 4 weeks during the 2 previous months; no
prior sorafenib-related toxicity

- previous conventional or drug eluting TACE unless it was performed at least 6 months
prior to screening phase

- history of organ allograft

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

survival

Outcome Description:

primary endpoint is overall survival measured from time of randomization

Outcome Time Frame:

from time of randomization up to 36 months

Safety Issue:

No

Principal Investigator

Vincenzo Mazzaferro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Tumori Nazionale, Milan, Italy

Authority:

United States: Food and Drug Administration

Study ID:

TS-104

NCT ID:

NCT01887717

Start Date:

June 2013

Completion Date:

December 2017

Related Keywords:

  • Unresectable Hepatocellular Carcinoma With Portal Vein Thrombosis
  • hepatocellular carcinoma
  • portal vein thrombosis
  • Carcinoma
  • Thrombosis
  • Venous Thrombosis
  • Carcinoma, Hepatocellular

Name

Location

Northwestern Medical Faculty Foundation, Div of Hematology/OncologyChicago, Illinois  60611