Liver Cancer
Conditions
Brief summary
Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). cTACE is a procedure in which chemotherapy drugs are injected, followed by an injection of small beads to block the tumor-feeding arteries. Doxorubicin is a chemotherapeutic agent used in the cTACE procedure. This study will examine doxorubicin pharmacokinetics in patients who: 1) receive whole liver cTACE; and 2) receive super-selective CTACE (i.e., delivered in close proximity to the tumor).
Detailed description
Patients with primary and secondary liver cancer may participate in this study. The purpose is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization (cTACE). A pharmacokinetics profile (PK profile) will be constructed and will include peak of plasma concentration (Cmax), time of maximum concentration (TMax), and area under the concentration curve (AUC). This composite measure will be used to compare patients in cTACE lobar administration and cTACE superselective administration. In addition, the PK profile will be correlated with toxicity, tumor burden, body surface area, and gender. Feasibility and safety will also be assessed.
Interventions
DRUGwhole liver lobe cTACE doxorubicin
Doxorubicin CTACE administered in a whole liver lobe manner.
DRUGsuperselective cTACE doxorubicin
Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.
Sponsors
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Histologically, cytologically, or radiologically confirmed liver dominant or liver only malignancy. 3. Preserved liver function (Child-Pugh A-B class) without significant liver decompensation. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry. 5. Measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). 6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and international normalized ratio. 7. May be enrolled with a history of prior liver directed intra-arterial therapy if intra-arterial therapy to the target lesion occured \> 1 year prior to enrollment date. Intra-arterial therapy to different targets within 1 year prior to enrollment date will not exclude subjects.
Exclusion criteria
1. Serum total bilirubin \> 3.0 mg/dL 2. Creatinine \> 2.0 mg/dL 3. Platelets \< 50000/µL 4. Complete portal vein thrombosis with reversal of flow 5. Ascites (trace ascites on imaging is acceptable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Profile-- Peak of Plasma Concentration | 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose | 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. |
| Pharmacokinetics Profile-- Area Under the Concentration Time Curve | 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose | Area 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. |
| Pharmacokinetics Profile-- Time of Maximum Concentration | 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose | Median 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. |
| Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose | 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. |
| Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose | Area 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | up to 4 weeks post cTACE | Adverse events assessed by CTCAE 5.0 and stratified by Lipiodol distribution. 30 patients were reviewed for toxicities. |
| Number of Participants With Technical Success of cTACE Procedure. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Superselective cTACE (2+ Segments) | Whole Liver Lobe cTACE Doxorubicin | Total | Superselective cTACE Doxorubicin (One Segment) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 2 Participants | 13 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 8 Participants | 17 Participants | 6 Participants |
| Age, Continuous | 66.8 years | 59.1 years | 63.2 years | 63.7 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 22 Participants | 7 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 30 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 25 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 10 / 10 | 9 / 10 | 10 / 10 |
| serious Total, serious adverse events | 1 / 10 | 1 / 10 | 0 / 10 |
Outcome results
Primary
Pharmacokinetics Profile-- Area Under the Concentration Time Curve
Area 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.
Time frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve | Doxorubicin AUC | 114.79 ng*h/mL | Standard Deviation 109.53 |
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve | Doxorubicinol AUC | 31.61 ng*h/mL | Standard Deviation 57.78 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve | Doxorubicin AUC | 195.80 ng*h/mL | Standard Deviation 199.4 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve | Doxorubicinol AUC | 62.27 ng*h/mL | Standard Deviation 105.66 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Area Under the Concentration Time Curve | Doxorubicin AUC | 307.87 ng*h/mL | Standard Deviation 195.69 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Area Under the Concentration Time Curve | Doxorubicinol AUC | 79.37 ng*h/mL | Standard Deviation 93.67 |
Primary
Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized)
Area 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.
Time frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | Doxorubicin dose normalized AUC | 2.87 ng*h/mL/mg | Standard Deviation 1.95 |
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | Doxorubicinol dose normalized AUC | 0.63 ng*h/mL/mg | Standard Deviation 1.16 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | Doxorubicin dose normalized AUC | 4.44 ng*h/mL/mg | Standard Deviation 4 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | Doxorubicinol dose normalized AUC | 1.32 ng*h/mL/mg | Standard Deviation 2.1 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | Doxorubicin dose normalized AUC | 7.10 ng*h/mL/mg | Standard Deviation 5.58 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Area Under the Concentration Time Curve (Dose Normalized) | Doxorubicinol dose normalized AUC | 1.91 ng*h/mL/mg | Standard Deviation 2.39 |
Comparison: To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicin.p-value: 0.023Kruskal-Wallis
Comparison: To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicinol.p-value: 0.041Kruskal-Wallis
Primary
Pharmacokinetics Profile-- Peak of Plasma Concentration
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.
Time frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Peak of Plasma Concentration | Doxorubicin Cmax | 83.94 ng/mL | Standard Deviation 75.09 |
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Peak of Plasma Concentration | Doxorubicinol Cmax | 3.79 ng/mL | Standard Deviation 5.52 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Peak of Plasma Concentration | Doxorubicin Cmax | 139.66 ng/mL | Standard Deviation 117.73 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Peak of Plasma Concentration | Doxorubicinol Cmax | 7.71 ng/mL | Standard Deviation 6.47 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Peak of Plasma Concentration | Doxorubicin Cmax | 334.35 ng/mL | Standard Deviation 215.18 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Peak of Plasma Concentration | Doxorubicinol Cmax | 15.87 ng/mL | Standard Deviation 7.57 |
Primary
Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized)
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.
Time frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | Doxorubicin Cmax normalized dose | 2.67 ng/mL/mg | Standard Deviation 2.02 |
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | Doxorubicinol Cmax normalized for dose | 0.08 ng/mL/mg | Standard Deviation 0.11 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | Doxorubicin Cmax normalized dose | 3.68 ng/mL/mg | Standard Deviation 4.2 |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | Doxorubicinol Cmax normalized for dose | 0.20 ng/mL/mg | Standard Deviation 0.22 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | Doxorubicin Cmax normalized dose | 7.11 ng/mL/mg | Standard Deviation 4.24 |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Peak of Plasma Concentration (Dose-normalized) | Doxorubicinol Cmax normalized for dose | 0.34 ng/mL/mg | Standard Deviation 0.15 |
Comparison: To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicin.p-value: 0.036Kruskal-Wallis
Comparison: To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicinol.p-value: 0.002Kruskal-Wallis
Primary
Pharmacokinetics Profile-- Time of Maximum Concentration
Median 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.
Time frame: 0, 5, 10, 20, 40 minutes, 1, 2, 4, 24 hours, and 3-4 weeks post dose
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Time of Maximum Concentration | Median Tmax doxorubicin | 0.53 hours |
| Superselective cTACE Doxorubicin (One Segment) | Pharmacokinetics Profile-- Time of Maximum Concentration | Median Tmax doxorubicinol | 1.20 hours |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Time of Maximum Concentration | Median Tmax doxorubicin | 0.60 hours |
| Superselective cTACE (2+ Segments) | Pharmacokinetics Profile-- Time of Maximum Concentration | Median Tmax doxorubicinol | 1.10 hours |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Time of Maximum Concentration | Median Tmax doxorubicin | 0.33 hours |
| Whole Liver Lobe cTACE Doxorubicin | Pharmacokinetics Profile-- Time of Maximum Concentration | Median Tmax doxorubicinol | 0.38 hours |
Secondary
Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0.
Adverse events assessed by CTCAE 5.0 and stratified by Lipiodol distribution. 30 patients were reviewed for toxicities.
Time frame: up to 4 weeks post cTACE
Population: 1 participant in the superselective cTACE (2+ segment) population did not experience any adverse events.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Alopecia (Grade 1) | 0 participants |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE Doxorubicin (One Segment) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Nausea (Grade 2) | 1 participants |
| Superselective cTACE Doxorubicin (One Segment) | 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 |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | 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) | 4 participants |
| Superselective cTACE (2+ Segments) | 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) | 0 participants |
| Superselective cTACE (2+ Segments) | 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) | 2 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | 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) | 2 participants |
| Superselective cTACE (2+ Segments) | 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) | 1 participants |
| Superselective cTACE (2+ Segments) | 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) | 0 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hypoalbuminemia (Grade 1) | 2 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyperglycemia (Grade 1) | 0 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyperkalemia (Grade 1) | 0 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyponatremia (Grade 4) | 1 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Anemia (Grade 1) | 0 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | 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) | 2 participants |
| Superselective cTACE (2+ Segments) | 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) | 2 participants |
| Superselective cTACE (2+ Segments) | 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) | 1 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | 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) | 0 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | 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) | 1 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Fatigue (Grade 1) | 0 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Fatigue (Grade 2) | 0 participants |
| Superselective cTACE (2+ Segments) | 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 |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Nausea (Grade 1) | 1 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Nausea (Grade 2) | 0 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Alopecia (Grade 1) | 0 participants |
| Superselective cTACE (2+ Segments) | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Anorexia (Grade 1) | 2 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 0 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hypoalbuminemia (Grade 1) | 2 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 0 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Nausea (Grade 1) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 3 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Fatigue (Grade 1) | 3 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Anemia (Grade 1) | 0 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Nausea (Grade 2) | 0 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Anemia (Grade 2) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyponatremia (Grade 1) | 2 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 2 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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) | 2 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyperkalemia (Grade 1) | 0 participants |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Alopecia (Grade 1) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyperglycemia (Grade 3) | 1 participants |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | 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 |
| Whole Liver Lobe cTACE Doxorubicin | Assessment and Frequency of Toxicities (Laboratory and Clinical Adverse Events) According to NCI Common Toxicity Criteria for AE (CTCAE) 5.0. | Hyperglycemia (Grade 1) | 2 participants |
Secondary
Number of Participants With Technical Success of cTACE Procedure.
Feasibility/technical success (yes/no) is measured by ability to administer a therapeutic dose, which is determined clinically.
Time frame: assessed at baseline (at the time of the cTACE procedure)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Superselective cTACE Doxorubicin (One Segment) | Number of Participants With Technical Success of cTACE Procedure. | 10 Participants |
| Superselective cTACE (2+ Segments) | Number of Participants With Technical Success of cTACE Procedure. | 10 Participants |
| Whole Liver Lobe cTACE Doxorubicin | Number of Participants With Technical Success of cTACE Procedure. | 10 Participants |