Trial Outcomes & Findings for Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer (NCT NCT02753881)
NCT ID: NCT02753881
Last Updated: 2020-08-03
Results Overview
Peak of plasma concentration (Cmax) of both doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments after dose normalization.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Results posted on
2020-08-03
Participant Flow
Participant milestones
| Measure |
Superselective cTACE Doxorubicin (One Segment)
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer
Baseline characteristics by cohort
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Continuous
|
63.7 years
n=5 Participants
|
66.8 years
n=7 Participants
|
59.1 years
n=5 Participants
|
63.2 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dosePopulation: 6 of 10 lobar, 7 of 10 single segment selective, and 9 of 10 multisegment patients received max 50mg dose of doxorubicin. Dose-normalized concentrations reported for all. Same distributions apply to doxorubicinol results. In addition, for 1 lobar patient and 8 selective patients, doxorubicinol concentrations were below limit of quantification.
Peak of plasma concentration (Cmax) of both doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments after dose normalization.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized)
Doxorubicin Cmax normalized dose
|
2.67 ng/mL/mg
Standard Deviation 2.02
|
3.68 ng/mL/mg
Standard Deviation 4.20
|
7.11 ng/mL/mg
Standard Deviation 4.24
|
|
Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized)
Doxorubicinol Cmax normalized for dose
|
0.08 ng/mL/mg
Standard Deviation 0.11
|
0.20 ng/mL/mg
Standard Deviation 0.22
|
0.34 ng/mL/mg
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dosePopulation: 6 of 10 lobar, 7 of 10 single segment selective, and 9 of 10 multisegment patients received max 50mg dose of doxorubicin. Dose-normalized concentrations reported for all. Same distributions apply to doxorubicinol results. In addition, for 1 lobar patient and 8 selective patients, doxorubicinol concentrations were below limit of quantification.
Peak of plasma concentration (Cmax) of doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Pharmacokinetics Profile-- Peak of Plasma Concentration
Doxorubicin Cmax
|
83.94 ng/mL
Standard Deviation 75.09
|
139.66 ng/mL
Standard Deviation 117.73
|
334.35 ng/mL
Standard Deviation 215.18
|
|
Pharmacokinetics Profile-- Peak of Plasma Concentration
Doxorubicinol Cmax
|
3.79 ng/mL
Standard Deviation 5.52
|
7.71 ng/mL
Standard Deviation 6.47
|
15.87 ng/mL
Standard Deviation 7.57
|
PRIMARY outcome
Timeframe: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post doseArea under the concentration time curve (AUC) reported for doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments after dose normalization.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized)
Doxorubicin dose normalized AUC
|
2.87 ng*h/mL/mg
Standard Deviation 1.95
|
4.44 ng*h/mL/mg
Standard Deviation 4.00
|
7.10 ng*h/mL/mg
Standard Deviation 5.58
|
|
Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized)
Doxorubicinol dose normalized AUC
|
0.63 ng*h/mL/mg
Standard Deviation 1.16
|
1.32 ng*h/mL/mg
Standard Deviation 2.10
|
1.91 ng*h/mL/mg
Standard Deviation 2.39
|
PRIMARY outcome
Timeframe: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post doseArea under the concentration time curve (AUC) reported for doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Pharmacokinetics Profile-- Area Under the Concentration Time Curve
Doxorubicin AUC
|
114.79 ng*h/mL
Standard Deviation 109.53
|
195.80 ng*h/mL
Standard Deviation 199.40
|
307.87 ng*h/mL
Standard Deviation 195.69
|
|
Pharmacokinetics Profile-- Area Under the Concentration Time Curve
Doxorubicinol AUC
|
31.61 ng*h/mL
Standard Deviation 57.78
|
62.27 ng*h/mL
Standard Deviation 105.66
|
79.37 ng*h/mL
Standard Deviation 93.67
|
PRIMARY outcome
Timeframe: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post doseMedian time of maximum concentration (Tmax) reported for doxorubicin and doxorubicinol reported for 10 lobar subjects, 10 superselective subjects with Lipiodol distribution to 1 segment, and 10 superselective subjects with Lipiodol distribution to multiple segments.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Pharmacokinetics Profile-- Time of Maximum Concentration
Median Tmax doxorubicin
|
0.53 hours
Interval 0.12 to 1.72
|
0.60 hours
Interval 0.17 to 1.22
|
0.33 hours
Interval 0.15 to 1.47
|
|
Pharmacokinetics Profile-- Time of Maximum Concentration
Median Tmax doxorubicinol
|
1.20 hours
Interval 0.37 to 4.27
|
1.10 hours
Interval 0.25 to 4.82
|
0.38 hours
Interval 0.15 to 1.47
|
SECONDARY outcome
Timeframe: assessed at baseline (at the time of the cTACE procedure)Feasibility/technical success (yes/no) is measured by ability to administer a therapeutic dose, which is determined clinically.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Number of Participants With Technical Success of cTACE Procedure.
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeks post cTACEPopulation: 1 participant in the superselective cTACE (2+ segment) population did not experience any adverse events.
Adverse events assessed by CTCAE 5.0 and stratified by Lipiodol distribution. 30 patients were reviewed for toxicities.
Outcome measures
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 Participants
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Anorexia (Grade 1)
|
1 participants
|
2 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Alkaline phosphatase increased (Grade 1)
|
0 participants
|
2 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Aspartate aminotransferase increased (Grade 1)
|
0 participants
|
0 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Alanine aminotransferase increased (Grade 2)
|
0 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
INR increased (Grade 1)
|
0 participants
|
2 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
INR increased (Grade 2)
|
0 participants
|
1 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Blood bilirubin increased (Grade 1)
|
2 participants
|
4 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Blood bilirubin increased (Grade 2)
|
1 participants
|
0 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Hypoalbuminemia (Grade 1)
|
3 participants
|
2 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Hyperglycemia (Grade 1)
|
3 participants
|
0 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Hyperglycemia (Grade 3)
|
0 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Hyperkalemia (Grade 1)
|
1 participants
|
0 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Hyponatremia (Grade 1)
|
1 participants
|
1 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Hyponatremia (Grade 4)
|
0 participants
|
1 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Anemia (Grade 1)
|
2 participants
|
0 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Anemia (Grade 2)
|
0 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Platelet count decreased (Grade 1)
|
0 participants
|
2 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Platelet count decreased (Grade 2)
|
2 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
White blood cell decreased (Grade 1)
|
1 participants
|
2 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Lymphocyte count decreased (Grade 1)
|
0 participants
|
1 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Lymphocyte count decreased (Grade 2)
|
2 participants
|
2 participants
|
2 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Neutrophil count decreased (Grade 1)
|
1 participants
|
0 participants
|
0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Neutrophil count decreased (Grade 3)
|
0 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Abdominal pain (Grade 1)
|
0 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Abdominal pain (Grade 2)
|
0 participants
|
1 participants
|
3 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Fatigue (Grade 1)
|
1 participants
|
0 participants
|
3 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Fatigue (Grade 2)
|
1 participants
|
0 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Fever (Grade 1)
|
1 participants
|
1 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Nausea (Grade 1)
|
0 participants
|
1 participants
|
1 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Nausea (Grade 2)
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1 participants
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0 participants
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0 participants
|
|
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Alopecia (Grade 1)
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0 participants
|
0 participants
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1 participants
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Adverse Events
Superselective cTACE Doxorubicin (One Segment)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
Superselective cTACE (2+ Segments)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Whole Liver Lobe cTACE Doxorubicin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 participants at risk
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 participants at risk
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 participants at risk
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
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Cardiac disorders
Cardiac arrest
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
Other adverse events
| Measure |
Superselective cTACE Doxorubicin (One Segment)
n=10 participants at risk
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol delivered to single segment.
|
Superselective cTACE (2+ Segments)
n=10 participants at risk
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a super-selective (close to the tumor) manner.
superselective cTACE doxorubicin: Doxorubicin CTACE administered in a super-selective (close to the tumor) manner. Lipiodol distributed to multiple segments.
|
Whole Liver Lobe cTACE Doxorubicin
n=10 participants at risk
Participants in this arm are administered 10 cc of chemotherapy, with 50mg doxorubicin and 10 mg of mitomycin-C via Lipiodol cTACE delivered in a lobar (whole liver) manner.
whole liver lobe cTACE doxorubicin: Doxorubicin CTACE administered in a whole liver lobe manner. Lipiodol distributed to entire liver lobe.
|
|---|---|---|---|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
INR increased
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
30.0%
3/10 • Number of events 3 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Blood bilirubin increased
|
30.0%
3/10 • Number of events 4 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
40.0%
4/10 • Number of events 5 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.0%
3/10 • Number of events 4 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
3/10 • Number of events 3 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
30.0%
3/10 • Number of events 3 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Platelet count decreased
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
30.0%
3/10 • Number of events 3 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
40.0%
4/10 • Number of events 4 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
40.0%
4/10 • Number of events 4 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
0.00%
0/10 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
20.0%
2/10 • Number of events 2 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
10.0%
1/10 • Number of events 1 • Up to 4 weeks post cTACE
Adverse events determined by regular laboratory tests and clinical visits, reviewed by investigators.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place