Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— MIRACLE I  

Official title:

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798134
• Other study ID #: TANDEM 2012-001 OUS
• Status: Completed
• Phase: N/A
• First received: December 6, 2012
• Last updated: March 17, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: CeloNova BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

This is a non-randomized, prospective, pilot, Multicenter Study of DEB-TACE using Doxorubicin-Loaded Embozene® Tandem™ Microspheres to treat HCC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a confirmed diagnosis of HCC according to the EASL criteria for diagnosis, and staged according to the 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. 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 mRECIST criteria

6. No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the MRI or 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

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

• 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, PT-INR > 2.0)

• AST and/or ALT >5x ULN or, when greater >250 U/L

• Known hepatofugal blood flow

• Arterio-venous shunt

• Arterio-portal shunt

• Main stem portal vein occlusion(point 6 in inclusion criteria)

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 (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 SIRT) for the treatment of primary liver cancer.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• TANDEM™

Locations

Country	Name	City	State
Germany	Kilinikum Darmstadt	Darmstadt	Hessen
Germany	Universitatsklinikum Essen	Essen	Nordrhein-Westfalen
Germany	Klinikum der Universitat Heidelberg	Heidelberg	Baden-Wuerttemberg
Germany	SLK-Kliniken Heilbronn GmbH	Heilbronn	Baden-Wuerttemberg
Germany	Klinikum Bogenhausen	Munchen	Bayern
Germany	University Hospital Regensburg	Regensburg
Germany	Klinikum Stuttgart- Katharinenhospital	Stuttgart	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
CeloNova BioSciences, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with SAEs	• Study Efficacy Goals: Freedom of primary tumor progression at 6 months (EASL and mRECIST); Average time to progression in all patients	Up to 90 days	Yes
Primary	Tumor Progression		Up to 6 months	Yes
Secondary	Local Tumor control	Secondary objectives include: Local tumor control based on the devascularization pattern. If any patient is referred to liver transplantation: Local tumor control based on microscopic analysis; 12 month survival	12 months	No