Hepatocellular CarcinomaMIRACLE INCT01798134
Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
A study testing TANDEM™ in people with Hepatocellular Carcinoma, run by Boston Scientific Corporation at 7 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TANDEM™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesGermany
- Study dates
- Dec 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
- Women who are pregnant or breast feeding
- Allergy to iodinated contrast used for angiography
- Tumour burden of more than 50% of liver
- Patients with objective signs of active bacterial, viral (human immunodeficiency virus (HIV)), or fungal infection
- Other primary malignancies or evidence of metastatic disease
- Patients previously treated with anthracyclines (other than doxorubicin).
- 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.
- Under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Kilinikum Darmstadt
Darmstadt, Hesse, 64283
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Klinikum der Universitat Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, 74078
Klinikum Bogenhausen
München, Bavaria, 81925
University Hospital Regensburg
Regensburg, 93042
Klinikum Stuttgart- Katharinenhospital
Stuttgart, Baden-Wurttemberg, 70174
About this study
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
- Being tested
- TANDEM™
- Keywords
- To show safety, and efficacy, investigational product
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TANDEM™Device
| Study group | Role | What they receive |
|---|---|---|
| DEB-TACE | Other | Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin Receives: Device: TANDEM™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Serious Adverse Event (SAE) at 30days
Measured: Up to 30 days
Freedom From Study Related SAE at 6 Months
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
12 Month Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gotz M Richter, MD, Principal investigator, Klinikum Stuttgart - Katharinenhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798134
- Sponsor's protocol ID
- TANDEM 2012-001 OUS
- Acronym
- MIRACLE I
- Status last verified
- Aug 2016
- First submitted
- 6 Dec 2012
- Last updated
- 3 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01798134
- Acronym / sponsor ID
- MIRACLE I / TANDEM 2012-001 OUS
- Conditions
- Hepatocellular Carcinoma
- Keywords
- To show safety, and efficacy, investigational product
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Posted 27 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE | Other | Device: TANDEM™Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE) Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (26 listed)
- 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:
- Women who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TANDEM™ | Device | DEB-TACE |
Primary outcome
Freedom From Serious Adverse Event (SAE) at 30days
Time frame: Up to 30 days
Freedom From Study Related SAE at 6 Months
Time frame: Up to 6 months
Freedom From Tumor Progression at 6 Months
Time frame: 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.
1 secondary outcome
12 Month Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gotz M Richter, MD principal investigator
Klinikum Stuttgart - Katharinenhospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TANDEM™ in people with Hepatocellular Carcinoma, run by Boston Scientific Corporation at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Serious Adverse Event (SAE) at 30days (time frame: Up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.