Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

NCT ID: NCT01798134

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEB-TACE

Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)

Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin

Group Type: OTHER

TANDEM™

Intervention Type: DEVICE

Interventions

TANDEM™

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

2. Subject is competent and willing to provide written informed consent in order to participate in the study

3. Adults (male or female) patients ≥ 18 years of age

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Child Pugh classification is 0-11

5. 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

6. No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the Magnetic resonance imaging (MRI) or Computed Tomography (CT)

7. Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study

8. No current infections requiring antibiotic therapy

9. Not actively on cumarin based anticoagulation or suffering from a known bleeding disorder

10. Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)

11. Expected survival more than 6 months

5. Women who are pregnant or breast feeding

6. Allergy to iodinated contrast used for angiography

7. Tumour burden of more than 50% of liver

8. Patients with objective signs of active bacterial, viral (human immunodeficiency virus (HIV)), or fungal infection

9. Other primary malignancies or evidence of metastatic disease

10. Patients previously treated with anthracyclines (other than doxorubicin).

11. Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk that would preclude the safe use of DEB-TACE.

12. Under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.

13. Under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including Selective Internal Radiation Therapy (SIRT)) for the treatment of primary liver cancer.

Exclusion Criteria

1. ECOG performance status >2; or Child-Pugh class C11 or more, or ASA class 5

2. Bilirubin levels >3 mg/dl

3. HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread

4. 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
• Arterio-portal shunt

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gotz M Richter, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Stuttgart - Katharinenhospital

Locations

Klinikum der Universitat Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

SLK-Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg, Germany

Klinikum Stuttgart- Katharinenhospital

Stuttgart, Baden-Wurttemberg, Germany

Klinikum Bogenhausen

München, Bavaria, Germany

Kilinikum Darmstadt

Darmstadt, Hesse, Germany

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, Germany

University Hospital Regensburg

Regensburg, , Germany

Countries

Germany

Other Identifiers

TANDEM 2012-001 OUS

Identifier Type: -

Identifier Source: org_study_id