Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

NCT01798134 | Completed Results DMC

• 1 other identifier: TANDEM 2012-001 OUS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™ Microspheres to treat hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Keywords

To show safety; and efficacy; investigational product

Outcome Measures

Primary Outcomes (3)

• Freedom From Serious Adverse Event (SAE) at 30days

  Up to 30 days

• Freedom From Study Related SAE at 6 Months

  Up to 6 months

• Freedom From Tumor Progression at 6 Months

  Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.

  6 months

Secondary Outcomes (1)

• 12 Month Survival

  12 months

Study Arms (1)

DEB-TACE

OTHER

Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE) Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin

Device: TANDEM™

Interventions

TANDEM™ DEVICE

DEB-TACE

Eligibility Criteria

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

You may qualify if:

• Patients with a confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria for diagnosis, and staged according to the Barcelona clinic liver cancer (BCLC) criteria
• Subject is competent and willing to provide written informed consent in order to participate in the study
• Adults (male or female) patients ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Child Pugh classification is 0-11
• Multidonar or single nodular tumor ≥3-10cm, Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. Patient must have at least one tumor lesion that meets the following criteria: Lesion can be accurately measured in at least one dimension according to modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria
• No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the Magnetic resonance imaging (MRI) or Computed Tomography (CT)
• Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
• No current infections requiring antibiotic therapy
• Not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
• Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)
• Expected survival more than 6 months

You may not qualify if:

• ECOG performance status \>2; or Child-Pugh class C11 or more, or ASA class 5
• Bilirubin levels \>3 mg/dl
• HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread
• Patients in which any of the following are contraindicated or present:
• The use of doxorubicin
• MRI
• Hepatic embolization procedures
• White blood cell (WBC) \< 3000 cells/mm3
• neutrophil \< 1500 cells/mm3
• Cardiac ejection fraction \< 50 percent assessed by isotopic ventriculography, echocardiography or MR
• Elevated creatinine greater than or equal to 2.5 mg/dl
• Impaired clotting test (platelet count \< 5 x 104/mm3, Prothrombin time-International normalized ratio (PT-INR \> 2.0)
• aspartate transaminase (AST) and/or alanine transaminase (ALT) \>5x ULN or, when greater \>250 U/L
• Known hepatofugal blood flow
• Arterio-venous shunt

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

Klinikum der Universitat Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

SLK-Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg, 74078, Germany

Location

Klinikum Stuttgart- Katharinenhospital

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

Klinikum Bogenhausen

München, Bavaria, 81925, Germany

Location

Kilinikum Darmstadt

Darmstadt, Hesse, 64283, Germany

Location

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

University Hospital Regensburg

Regensburg, 93042, Germany

Location

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

Results Point of Contact

• Title: Senior Clinical Program Manager
• Organization: Boston Scientific Corporation

hansenj2@bsci.com

763-494-2172

Study Officials

• Gotz M Richter, MD

  Klinikum Stuttgart - Katharinenhospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: February 25, 2013
• Study Start: December 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 3, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-08

Locations

DE (7)