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Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein (YES-P)

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ClinicalTrials.gov Identifier: NCT01887717
Recruitment Status : Terminated (Poor Accrual.)
First Posted : June 27, 2013
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.

Brief Summary:
This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of patients with inoperable liver cancer and blockage of the portal vein.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: TheraSphere Drug: Sorafenib Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2013
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of care treatment
All patients in the Control group will receive SOC treatment with sorafenib in accordance with the package insert.
Drug: Sorafenib
standard of care therapy for treatment of advanced hepatocellular carcinoma
Other Name: Nexavar

Experimental: TheraSphere
Patients will receive treatment with yttrium-90 microspheres in accordance with the package insert.
Device: TheraSphere
Treatment with TheraSphere
Other Name: yttrium-90 microspheres




Primary Outcome Measures :
  1. survival [ Time Frame: from time of randomization up to 36 months ]
    primary endpoint is overall survival measured from time of randomization


Secondary Outcome Measures :
  1. adverse events [ Time Frame: from randomization up to 36 months ]
    Adverse events classified according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE) will be assessed on the basis of frequency and severity

  2. time to progression [ Time Frame: from randomization up to 36 months ]
    Radiological time to progression will be assessed using multiple methodologies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years of age, regardless of race of gender
  • Advanced unresectable hepatocellular carcinoma with branch portal vein thrombosis (confirmed by non-invasive criteria EASL/AASLD, mandatory by histology in non-cirrhotic patients); can be naive or recurrent HCC after curative treatment (> 6 months before randomization)
  • Unilobar disease
  • Child Pugh A
  • Tumor volume ≤ 70% of liver volume (determined by visual estimation)
  • At least one uni-dimensional HCC target lesion assessable by CT or MRI according to RECIST 1.1
  • ECOG Performance Status 0-1
  • Platelets ≥ 50 X 10³/µL
  • WBC ≥ 1.5 X10³/µL
  • AST/ALT ≤ 5 X upper limit of normal
  • Creatinine ≤ 2.0 mg/dL
  • Life expectancy > 3 months
  • Signed informed consent

Exclusion Criteria:

  • Confirmed extra hepatic metastases. Patients with indeterminate hepatic hilar lymph nodes up to 2.5 cm in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5 cm, or multiple smaller lesions with a total diameter ≤ 2 cm) may be included if metastatic disease is deemed unlikely
  • Known contraindication to standard-of-care sorafenib including allergic reaction, pill swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, renal failure including dialysis
  • Evidence of hepatic vein invasion or caval thrombosis
  • Evidence of chronic obstructive pulmonary disease
  • Indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
  • Previous treatment with sorafenib for more than 4 weeks during the previous 2 months; prior sorafenib-related toxicity
  • Initiation of anti-tumor therapy including chemotherapy or investigational drug treatment within 30 days before beginning study
  • Prior TACE < 6 months prior to screening phase in case of patients progressing from an intermediate to an advanced stage due to occurrence of PVT
  • Patients cannot be on a transplant list
  • History of organ allograft
  • Contraindications to angiography or selective visceral catheterization
  • History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
  • Prior external beam radiation therapy to the liver
  • Evidence of continuing adverse effect of prior therapy
  • Active GI bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents
  • Evidence of any disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment
  • Females of child-bearing potential must have a negative serum test Participation in concurrent clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887717


Locations
United States, Illinois
Northwestern Medical Faculty Foundation, Div of Hematology/Oncology
Chicago, Illinois, United States, 60611
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
France
Paoli-Calmettes Institute
Marseille, France, 13273
Italy
UO Radiologia, Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
ASO-Santa Croce e Carle di Cuneo
Cuneo, Italy, 12100
Fondazione IRCCS Ca Grande
Milano, Italy, 20122
S.C Radiologia Interventistica, A.O.Ospedale Niguarda Ca Granda
Milano, Italy, 20162
Fondazione Istituto Nazionale Tumori di Milano
Milano, Italy, I-20133
Azienda Ospedaliera Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy, 90147
University of Pisa
Pisa, Italy, 56100
Policlinico A. Gemelli
Rome, Italy, 8 - 00168
Spain
Hospital Clínic Barcelona. IDIBAPS. CIBEREHD. Liver Unit
Barcelona, Spain, 08036
Bulevar Sur s/n
Madrid, Spain, 28041
Hospital Universitario Puerta de Hierro, Gastroenterology & Hepatology Dept
Madrid, Spain, 28222
Hospital Universitari i Politecnic la Fe
Valencia, Spain, 46026
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2WB
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Vincenzo Mazzaferro, MD Istituto Tumori Nazionale, Milan, Italy
Principal Investigator: Riad Salem, MD Northwestern University Chicago Illinois

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01887717     History of Changes
Other Study ID Numbers: TS-104
2012-005375-14 ( EudraCT Number )
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by BTG International Inc.:
hepatocellular carcinoma
portal vein thrombosis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action