Hepatocellular Carcinoma
Conditions
Keywords
To show safety, and efficacy, investigational product
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).
Interventions
DEVICETANDEM™
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 12 Month Survival | 12 months |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DEB-TACE Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™ | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 2 |
| Overall Study | Liver transplant/surgery | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | DEB-TACE |
|---|---|
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment Germany | 25 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 25 |
| serious Total, serious adverse events | 10 / 25 |
Outcome results
Primary
Freedom From Serious Adverse Event (SAE) at 30days
Time frame: Up to 30 days
Population: One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEB-TACE | Freedom From Serious Adverse Event (SAE) at 30days | 22 participants |
Primary
Freedom From Study Related SAE at 6 Months
Time frame: Up to 6 months
Population: One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEB-TACE | Freedom From Study Related SAE at 6 Months | 21 participants |
Primary
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.
Time frame: 6 months
Population: For efficacy outcomes, there were 21 participants with imaging to assess tumor response. No imaging was available for the other participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEB-TACE | Freedom From Tumor Progression at 6 Months | 20 participants |
Secondary
12 Month Survival
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEB-TACE | 12 Month Survival | 14 participants |