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Risk to benefit ratio is not acceptable
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TACE is frequently offered to patients with baseline hepatic dysfunction with the purpose of diminishing hepatic tumor burden while patients await transplantation. Without this therapeutic measure, disease may progress beyond UNOS T2 criteria required for organ allocation.
The purpose of the study is to determine whether transarterial chemoembolization using doxorubicin-eluting beads (DEB-TACE) can be used safely and effectively to treat patients with liver-only hepatocellular carcinoma (HCC) and baseline hepatic dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB-TACE | Experimental | Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC Bead | Device | Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Observed Radiographic Response Rate (Measured by mRECIST) | Best observed radiographic response rate to Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) was defined as number of patients who had CR, PR, or SD as their best observed response divided by total number of patients with at least one available CT or MRI. Definition of mRECIST for Hepatocellular Carcinoma (HCC). Complete response (CR) = Disappearance of any intratumoral arterial enhancement in all target lesions. Partial response (PR)=At least a 30% decrease in sum of diameters of viable (enhancement in arterial phase) target lesions, taking as reference baseline sum of diameters of target lesions. Stable disease (SD)=Any cases that do not qualify for either partial response or progressive disease. Progressive disease (PD)=An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enh | 1 year |
| Number of Patients Who Developed New Severe Adverse Events | Number of patients who developed new severe adverse events according to NCI CTCAE version 4.0 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Best Observed Objective Radiographic Response by mRECIST | Best observed objective radiographic response was defined as the number of patients who had a complete response or partial response divided by total number of evaluable patients. Measured by mRECIST (see mRECIST definition in the description of the primary objective). | 6 months |
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Inclusion Criteria:
Adult male or female patients, age 18 years of age or older
Diagnosis of liver-only HCC based on European Association for the Study of the Liver (EASL) criteria (radiographic lesion appearance on contrast-enhanced CT or MRI, i.e. enhancement on early arterial phase, washout on portal venous phase with or without associated elevation of serum alpha-fetoprotein (AFP) level >200 Units Per Millilitre (U/ml)) or histologic confirmation of HCC diagnosis, whichever is applicable.
UNOS stage T1, T2, or T3 disease.
Candidates for liver transplantation (listed or screened) according to one of the following criteria:
At least one measurable site of disease in the liver according to RECIST version 1.1 and odified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
At least one of the following clinical, laboratory, or imaging parameters:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Fidelman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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17 patients were enrolled and completed study.
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| ID | Title | Description |
|---|---|---|
| FG000 | DEB-TACE | Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DEB-TACE #1 | Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first 1st debtace treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best Observed Radiographic Response Rate (Measured by mRECIST) | Best observed radiographic response rate to Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) was defined as number of patients who had CR, PR, or SD as their best observed response divided by total number of patients with at least one available CT or MRI. Definition of mRECIST for Hepatocellular Carcinoma (HCC). Complete response (CR) = Disappearance of any intratumoral arterial enhancement in all target lesions. Partial response (PR)=At least a 30% decrease in sum of diameters of viable (enhancement in arterial phase) target lesions, taking as reference baseline sum of diameters of target lesions. Stable disease (SD)=Any cases that do not qualify for either partial response or progressive disease. Progressive disease (PD)=An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enh | Best observed radiographic response for all patients who had at least one follow-up cross-sectional imaging study | Posted | Count of Participants | Participants | 1 year |
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEB-TACE | Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first LC Bead: Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic failure | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Curt Johanson | University of California, San Francisco | 415-353-2310 | curt.johanson@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2015 | Apr 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
|
| Time to Untreatable Progression (TTUP) |
TTUP is defined as time (months) from the first on-study DEB-TACE to development of radiographic disease progression untreatable by liver-directed percutaneous or surgical methods (by mRECIST). |
| 1 year |
| Time to Progression (TTP) | Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST. | 1 year |
| Time to Hepatic Progression (TTHP) | Time to hepatic progression (TTHP) was defined as a period of time from the first on-study DEB-TACE till development of radiographic evidence of disease progression in the liver by mRECIST. | 1 year |
| Progression Free Survival (PFS) Rate | Progression free survival rate was defined as the number of patients who were alive and free from radiographic progression by mRECIST at pre-defined time periods. PFS rate was calculated at 3 months, 6 months, 12 months, and 24 months | 3 months, 6 months, 12 Months, and 24 months |
| Proportion of Patients With Alpha-fetoprotein (AFP) Response With ≥ 50% Decline From Baseline | This measure was defined as the number of patients with alpha-fetoprotein (AFP) response with ≥ 50% decline from baseline (in patients with baseline level ≥ 20) after DEB-TACE. | 1 year |
| Left Ventricular Ejection Fraction (LVEF) | Left ventricular ejection fraction (LVEF) was measured as percent contraction prior to the first DEB-TACE and 1 month following last planned DEB-TACE. Median LVEF and full range were reported. | Baseline, 1 month following last planned DEB-TACE |
| Median Area Under Curve (AUC) | Area under curve for doxorubicin concentration in the serum over 7 days was measured by obtaining serum doxorubicin concentration samples at predose, 5 min, 20 min, 40 min, 60 min, 120 min, 6 hours, 24 hours, 7 days time points. A graph of serum doxorubicin concentration over time was then plotted for each of the 17 patients, and the area under the curve for each of the 17 patients was calculated. Pharmacokinetic sampling was performed only during each of the first planned DEB-TACE procedures. | 7 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | DEB-TACE | Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first LC Bead: Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE): Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first. |
|
|
| Primary | Number of Patients Who Developed New Severe Adverse Events | Number of patients who developed new severe adverse events according to NCI CTCAE version 4.0 | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Best Observed Objective Radiographic Response by mRECIST | Best observed objective radiographic response was defined as the number of patients who had a complete response or partial response divided by total number of evaluable patients. Measured by mRECIST (see mRECIST definition in the description of the primary objective). | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Time to Untreatable Progression (TTUP) | TTUP is defined as time (months) from the first on-study DEB-TACE to development of radiographic disease progression untreatable by liver-directed percutaneous or surgical methods (by mRECIST). | months | Posted | Median | Full Range | Months | 1 year |
|
|
|
| Secondary | Time to Progression (TTP) | Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST. | Posted | Median | Full Range | Months | 1 year |
|
|
|
| Secondary | Time to Hepatic Progression (TTHP) | Time to hepatic progression (TTHP) was defined as a period of time from the first on-study DEB-TACE till development of radiographic evidence of disease progression in the liver by mRECIST. | Posted | Median | Full Range | Months | 1 year |
|
|
|
| Secondary | Progression Free Survival (PFS) Rate | Progression free survival rate was defined as the number of patients who were alive and free from radiographic progression by mRECIST at pre-defined time periods. PFS rate was calculated at 3 months, 6 months, 12 months, and 24 months | Posted | Number | participants | 3 months, 6 months, 12 Months, and 24 months |
|
|
|
| Secondary | Proportion of Patients With Alpha-fetoprotein (AFP) Response With ≥ 50% Decline From Baseline | This measure was defined as the number of patients with alpha-fetoprotein (AFP) response with ≥ 50% decline from baseline (in patients with baseline level ≥ 20) after DEB-TACE. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Left ventricular ejection fraction (LVEF) was measured as percent contraction prior to the first DEB-TACE and 1 month following last planned DEB-TACE. Median LVEF and full range were reported. | Posted | Median | Full Range | percent contraction | Baseline, 1 month following last planned DEB-TACE |
|
|
|
| Secondary | Median Area Under Curve (AUC) | Area under curve for doxorubicin concentration in the serum over 7 days was measured by obtaining serum doxorubicin concentration samples at predose, 5 min, 20 min, 40 min, 60 min, 120 min, 6 hours, 24 hours, 7 days time points. A graph of serum doxorubicin concentration over time was then plotted for each of the 17 patients, and the area under the curve for each of the 17 patients was calculated. Pharmacokinetic sampling was performed only during each of the first planned DEB-TACE procedures. | Posted | Median | Full Range | ng/ml-hr | 7 days |
|
|
|
| 12 |
| 17 |
| 13 |
| 17 |
| 17 |
| 17 |
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Edema of legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hyperbilirubinemia | Gastrointestinal disorders | Systematic Assessment |
|
| AST elevation | Gastrointestinal disorders | Systematic Assessment |
|
| Hyponatremia | Renal and urinary disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Hiccoughs | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| ALT elevation | Gastrointestinal disorders | Systematic Assessment |
|
| Creatinine elevation | Renal and urinary disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| Title | Measurements |
|---|---|
|
| Pain |
|
| Hyperbilirubinemia |
|
| AST elevation |
|
| Hyponatremia |
|
| Anemia |
|
| Thrombocytopenia |
|
| Creatinine elevation |
|
| Title | Measurements |
|---|
|
| 24 months |
|