Trial Outcomes & Findings for Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma (NCT NCT02007954)
NCT ID: NCT02007954
Last Updated: 2017-08-11
Results Overview
Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
6 months
Results posted on
2017-08-11
Participant Flow
The study enrolled patients diagnosed with unresectable hepatocellular carcinoma without prior locoregional therapy or concurrent anticancer therapy. Patients were enrolled from February 2014 to January 2015, with the last patient completing follow-up in August 2015.
Participant milestones
| Measure |
DEBDOX
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
Completed First TACE
|
24
|
|
Overall Study
Completed First Clinical and Imaging
|
23
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
DEBDOX
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Overall Study
Received liver transplant
|
3
|
|
Overall Study
Switch in treatment modality
|
2
|
|
Overall Study
Disease progression and unrelated AE
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
Baseline characteristics by cohort
| Measure |
DEBDOX
n=24 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Age, Continuous
|
62.5 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic · White
|
15 Participants
n=23 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Non-Hispanic · African American
|
7 Participants
n=23 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Non-Hispanic · Asian
|
1 Participants
n=23 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Non-Hispanic · Unknown
|
0 Participants
n=23 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Unknown · White
|
0 Participants
n=1 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Unknown · African American
|
0 Participants
n=1 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Unknown · Asian
|
0 Participants
n=1 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Race/Ethnicity, Customized
Unknown · Unknown
|
1 Participants
n=1 Participants • Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The 24 patients received a total of 50 DEBDOX-M1 TACE procedures.
Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.
Outcome measures
| Measure |
DEBDOX
n=50 DEBDOX-M1 treatments
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Success of DEBDOX-M1 Procedure as a Measure of Feasibility
|
100 percentage of successful treatments
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 30-day toxicity report of device-related adverse events for all 24 patients with classification and grading based on CTCAE v4.0.
For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE.
Outcome measures
| Measure |
DEBDOX
n=24 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Nausea/Vomiting
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hypertension
|
6 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Anorexia
|
4 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Fatigue
|
2 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Fever
|
2 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Weight loss
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Weight gain
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Insomnia
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hyperglycemia
|
5 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hypoglycemia
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Ascites
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Diarrhea
|
2 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Constipation
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Gas
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Groin hematoma
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hyperbilirubinemia
|
2 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hypoalbuminemia
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Cellulitis
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Headache
|
2 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Confusion
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Abdominal non-specific pain
|
2 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Pain - general
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Pain - right shoulder
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hypercreatininemia
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hypokalemia
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hyponatremia
|
3 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Grade 3 Elevated Transaminase
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Hypoxia
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Cardiac arrest
|
1 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Total Grade 1-2 adverse events
|
46 Adverse Events
|
|
Collection of Adverse Events Related to Study Device as a Measure of Safety
Total Grade 3 or higher adverse events
|
3 Adverse Events
|
SECONDARY outcome
Timeframe: 1 monthEfficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments. Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference. Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1. Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1. Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1.
Outcome measures
| Measure |
DEBDOX
n=23 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Efficacy - Tumor Response by EASL
Complete Response
|
5 Participants
|
|
Efficacy - Tumor Response by EASL
Partial Response
|
5 Participants
|
|
Efficacy - Tumor Response by EASL
Stable Disease
|
10 Participants
|
|
Efficacy - Tumor Response by EASL
Progressive Disease
|
3 Participants
|
|
Efficacy - Tumor Response by EASL
Objective response (CR + PR)
|
10 Participants
|
|
Efficacy - Tumor Response by EASL
Disease control rate (CR + PR + SD)
|
20 Participants
|
SECONDARY outcome
Timeframe: 1 monthEfficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions. Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease. Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions.
Outcome measures
| Measure |
DEBDOX
n=23 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Efficacy - Tumor Response by qEASL
Complete Response
|
5 Participants
|
|
Efficacy - Tumor Response by qEASL
Partial Response
|
4 Participants
|
|
Efficacy - Tumor Response by qEASL
Stable Disease
|
13 Participants
|
|
Efficacy - Tumor Response by qEASL
Progressive Disease
|
1 Participants
|
|
Efficacy - Tumor Response by qEASL
Objective response (CR + PR)
|
9 Participants
|
|
Efficacy - Tumor Response by qEASL
Disease control rate (CR + PR + SD)
|
22 Participants
|
SECONDARY outcome
Timeframe: 1 monthEfficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD.
Outcome measures
| Measure |
DEBDOX
n=23 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Efficacy - Tumor Response by mRECIST
Complete Response
|
5 Participants
|
|
Efficacy - Tumor Response by mRECIST
Partial Response
|
5 Participants
|
|
Efficacy - Tumor Response by mRECIST
Stable Disease
|
11 Participants
|
|
Efficacy - Tumor Response by mRECIST
Progressive Disease
|
2 Participants
|
|
Efficacy - Tumor Response by mRECIST
Objective response (CR + PR)
|
10 Participants
|
|
Efficacy - Tumor Response by mRECIST
Disease control rate (CR + PR + SD)
|
21 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe number of patients who underwent a liver transplantation following treatment on this protocol.
Outcome measures
| Measure |
DEBDOX
n=24 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 23 out of 24 patients analyzed due to one patient not completing AFP post-TACE.
The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure.
Outcome measures
| Measure |
DEBDOX
n=23 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
AFP Tumor Marker Pre- and Post-treatment
Pre-M1 TACE
|
289.7 ng/mL
Interval 1.8 to 4152.0
|
|
AFP Tumor Marker Pre- and Post-treatment
Post-M1 TACE
|
145.4 ng/mL
Interval 1.3 to 1706.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPK analysis of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin.
Outcome measures
| Measure |
DEBDOX
n=10 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Exploratory Endpoint - Pharmacokinetic (PK) Profile of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE
|
139.9 ng/mL
Standard Deviation 98.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursTotal drug exposure over time (AUC) of doxorubicin and its metabolite doxorubicinol post DEBDOX in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..
Outcome measures
| Measure |
DEBDOX
n=10 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Exploratory Endpoint - Total Drug Exposure Over Time (AUC) of Doxorubicin and Doxorubicinol Post TACE
|
327 ng*h/mL
Standard Deviation 366
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursTime taken to reach maximum concentration (Tmax) of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..
Outcome measures
| Measure |
DEBDOX
n=10 Participants
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Exploratory Endpoint - Tmax of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE
|
6.6 minutes
Standard Deviation 3.6
|
Adverse Events
DEBDOX
Serious events: 4 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DEBDOX
n=24 participants at risk
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Vascular disorders
Thromboembolic event
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Renal and urinary disorders
Renal failure
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
Other adverse events
| Measure |
DEBDOX
n=24 participants at risk
DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
41.7%
10/24 • Number of events 12 • Adverse events collected over the participant's duration on study (6 months)
|
|
Blood and lymphatic system disorders
Anemia
|
45.8%
11/24 • Number of events 11 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
6/24 • Number of events 6 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Ascites
|
12.5%
3/24 • Number of events 4 • Adverse events collected over the participant's duration on study (6 months)
|
|
Hepatobiliary disorders
Intrahepatic biloma
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Pain
|
29.2%
7/24 • Number of events 9 • Adverse events collected over the participant's duration on study (6 months)
|
|
Skin and subcutaneous tissue disorders
Skin abscess
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
3/24 • Number of events 3 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Chills
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Edema limbs
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
4/24 • Number of events 4 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Alkaline phosphatase increased
|
41.7%
10/24 • Number of events 12 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Aspartate aminotransferase
|
37.5%
9/24 • Number of events 10 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
INR increased
|
16.7%
4/24 • Number of events 4 • Adverse events collected over the participant's duration on study (6 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Fatigue
|
54.2%
13/24 • Number of events 19 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Fever
|
16.7%
4/24 • Number of events 4 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Flu like symptoms
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Vascular disorders
Hematoma
|
12.5%
3/24 • Number of events 3 • Adverse events collected over the participant's duration on study (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Blood bilirubin increased
|
45.8%
11/24 • Number of events 14 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Creatinine increased
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
62.5%
15/24 • Number of events 22 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Vascular disorders
Hypertension
|
58.3%
14/24 • Number of events 16 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
12/24 • Number of events 18 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.8%
5/24 • Number of events 8 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Hemoglobin increased
|
4.2%
1/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
White blood cell decreased
|
29.2%
7/24 • Number of events 12 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Lymphocyte count decreased
|
45.8%
11/24 • Number of events 14 • Adverse events collected over the participant's duration on study (6 months)
|
|
General disorders
Malaise
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
6/24 • Number of events 6 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
3/24 • Number of events 3 • Adverse events collected over the participant's duration on study (6 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Infections and infestations
Skin infection
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Platelet count decreased
|
20.8%
5/24 • Number of events 5 • Adverse events collected over the participant's duration on study (6 months)
|
|
Infections and infestations
Upper respiratory infection
|
4.2%
1/24 • Number of events 1 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Weight gain
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
|
Investigations
Weight loss
|
8.3%
2/24 • Number of events 2 • Adverse events collected over the participant's duration on study (6 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place