Clinical trial NCT01798134: Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
Official title: Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: To show safety
and efficacy
investigational product
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

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
   * 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 (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.

Primary outcomes:
measure: Freedom From Serious Adverse Event (SAE) at 30days
timeFrame: Up to 30 days
measure: Freedom From Study Related SAE at 6 Months
timeFrame: Up to 6 months
measure: Freedom From Tumor Progression at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: 12 Month Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Klinikum der Universitat Heidelberg
state: Baden-Wuerttemberg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart- Katharinenhospital
state: Baden-Wuerttemberg
city: Munchen
country: Germany
facility: Klinikum Bogenhausen
state: Bayern
city: Darmstadt
country: Germany
facility: Kilinikum Darmstadt
state: Hessen
city: Essen
country: Germany
facility: Universitatsklinikum Essen
state: Nordrhein-Westfalen
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: Klinikum Stuttgart - Katharinenhospital
name: Gotz M Richter, MD
role: PRINCIPAL_INVESTIGATOR
References: