Trial Outcomes & Findings for Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma (NCT NCT01798134)
NCT ID: NCT01798134
Last Updated: 2016-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2016-10-03
Participant Flow
Participant milestones
| Measure |
DEB-TACE
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
DEB-TACE
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Liver transplant/surgery
|
4
|
Baseline Characteristics
Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
DEB-TACE
n=25 Participants
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: 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.
Outcome measures
| Measure |
DEB-TACE
n=24 Participants
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Freedom From Serious Adverse Event (SAE) at 30days
|
22 participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: 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.
Outcome measures
| Measure |
DEB-TACE
n=24 Participants
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Freedom From Study Related SAE at 6 Months
|
21 participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: For efficacy outcomes, there were 21 participants with imaging to assess tumor response. No imaging was available for the other participants.
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.
Outcome measures
| Measure |
DEB-TACE
n=21 Participants
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Freedom From Tumor Progression at 6 Months
|
20 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
DEB-TACE
n=25 Participants
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
12 Month Survival
|
14 participants
|
Adverse Events
DEB-TACE
Serious events: 10 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DEB-TACE
n=25 participants at risk
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Injury, poisoning and procedural complications
Spinal column injury
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic Failure
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
Liver abscess
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hepatic encephalopathy
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic necrosis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
Peritonitis bacterial
|
4.0%
1/25 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Investigations
Haemoglobin decreased
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ataxia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
4.0%
1/25 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
DEB-TACE
n=25 participants at risk
Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)
Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
TANDEM™
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
28.0%
7/25 • Number of events 12 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.0%
4/25 • Number of events 8 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
12.0%
3/25 • Number of events 8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Investigations
Blood creatinine increased
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
Investigations
Blood potassium decreased
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Number of events 7 • 1 year
|
|
Investigations
C-reactive protein increased
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Investigations
Haemoglobin decreased
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Vascular disorders
Hypertension
|
12.0%
3/25 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
2/25 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
28.0%
7/25 • Number of events 10 • 1 year
|
|
General disorders
Oedema peripheral
|
8.0%
2/25 • Number of events 3 • 1 year
|
|
General disorders
Pain
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.0%
3/25 • Number of events 4 • 1 year
|
|
General disorders
Pyrexia
|
24.0%
6/25 • Number of events 8 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
16.0%
4/25 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • 1 year
|
Additional Information
Senior Clinical Program Manager
Boston Scientific Corporation
Phone: 763-494-2172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60