Trial Outcomes & Findings for Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (NCT NCT00539643)
NCT ID: NCT00539643
Last Updated: 2023-08-18
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
2 to 3 weeks
Results posted on
2023-08-18
Participant Flow
Participant milestones
| Measure |
Bead Arm
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
|
Overall Study
COMPLETED
|
45
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Bead Arm
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Bead Arm
n=51 Participants
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 Participants
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
66 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 to 3 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bead Arm
n=51 Participants
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 Participants
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Response to Treatment by RECIST Criteria
Participants With Response
|
3 Participants
|
3 Participants
|
|
Response to Treatment by RECIST Criteria
Participants Without Response
|
48 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 1 yearToxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
Outcome measures
| Measure |
Bead Arm
n=51 Participants
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 Participants
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Number of Participants Evaluated for Toxicity
|
51 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 1 yearProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Bead Arm
n=51 Participants
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 Participants
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Progression Free Survival
|
6.2 months
Standard Deviation .11
|
2.8 months
Standard Deviation .11
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Bead Arm
n=51 Participants
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 Participants
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Overall Survival
Alive
|
3 Participants
|
3 Participants
|
|
Overall Survival
Dead
|
48 Participants
|
47 Participants
|
Adverse Events
Bead Arm
Serious events: 48 serious events
Other events: 33 other events
Deaths: 48 deaths
Bead + Dox Arm
Serious events: 47 serious events
Other events: 28 other events
Deaths: 47 deaths
Serious adverse events
| Measure |
Bead Arm
n=51 participants at risk
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 participants at risk
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
3.9%
2/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Hepatobiliary disorders
Liver abscess
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Hepatobiliary disorders
Liver failure (transient)
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Injury, poisoning and procedural complications
Puncture Site
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Vascular disorders
Pulmonary embolus
|
2.0%
1/51 • 1 year
|
8.0%
4/50 • 1 year
|
|
General disorders
Death not assoc w CTCAE term- Death
|
5.9%
3/51 • 1 year
|
8.0%
4/50 • 1 year
|
|
General disorders
Death not assoc w CTCAE term- Sudden death
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
7.8%
4/51 • 1 year
|
10.0%
5/50 • 1 year
|
|
General disorders
Death due to disease progression
|
78.4%
40/51 • 1 year
|
76.0%
38/50 • 1 year
|
Other adverse events
| Measure |
Bead Arm
n=51 participants at risk
Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis
|
Bead + Dox Arm
n=50 participants at risk
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Investigations
Alkaline Phosphatase
|
17.6%
9/51 • 1 year
|
18.0%
9/50 • 1 year
|
|
Immune system disorders
Allerg react/hypersens (incl drug fever)
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Investigations
ALT, SGPT
|
27.5%
14/51 • 1 year
|
22.0%
11/50 • 1 year
|
|
Investigations
Amylase
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
5.9%
3/51 • 1 year
|
4.0%
2/50 • 1 year
|
|
Investigations
AST, SGOT
|
13.7%
7/51 • 1 year
|
12.0%
6/50 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
2/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
7.8%
4/51 • 1 year
|
22.0%
11/50 • 1 year
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow, other
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
3.9%
2/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Investigations
Creatinine
|
2.0%
1/51 • 1 year
|
6.0%
3/50 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
2/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.9%
3/51 • 1 year
|
6.0%
3/50 • 1 year
|
|
General disorders
Fever (in the absence of neutropenia)
|
7.8%
4/51 • 1 year
|
6.0%
3/50 • 1 year
|
|
Gastrointestinal disorders
Gastritis (incl bile reflux gastritis)
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
9.8%
5/51 • 1 year
|
12.0%
6/50 • 1 year
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.9%
2/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage, Lower GI NOS
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage, Rectum
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage, Varices (esophageal)
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Hepatobiliary disorders
Hepatobiliary/Pancrease, other
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Gastrointestinal disorders
Ileus, GI (func obstruction of bowel)
|
3.9%
2/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Investigations
Inf norm ANC/gr1/2 neut- Pneumonia(lung)
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Infections and infestations
Inf unknown ANC-Cellulitis(skin)
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Urinary tract NOS
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Investigations
INR
|
2.0%
1/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Gastrointestinal disorders
Leak, GI- Biliary tree
|
2.0%
1/51 • 1 year
|
0.00%
0/50 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/51 • 1 year
|
4.0%
2/50 • 1 year
|
|
Investigations
Lipase
|
0.00%
0/51 • 1 year
|
2.0%
1/50 • 1 year
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
3.9%
2/51 • 1 year
|
12.0%
6/50 • 1 year
|
|
Investigations
Lymphopenia
|
5.9%
3/51 • 1 year
|
8.0%
4/50 • 1 year
|
Additional Information
Dr. Anne Covey, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6746
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place