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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00077927 | Other Identifier | JHMIRB |
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The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE) DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEBDOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEBDOX | Device | DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival. |
| Measure | Description | Time Frame |
|---|---|---|
| Success of DEBDOX-M1 Procedure as a Measure of Feasibility | Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma. | 6 months |
| Collection of Adverse Events Related to Study Device as a Measure of Safety | For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Tumor Response by EASL | Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments. Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference. Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1. Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1. Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint - Pharmacokinetic (PK) Profile of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE | PK analysis of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin. |
INCLUSION CRITERIA:
The patient has preserved liver function (Child-Pugh A-B class) without significant liver decompensation.
The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
The patient is age 18 years or older.
The patient has a life expectancy of > 12 weeks.
The patient has measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
The patient has adequate hematologic function as defined by the following criteria:
The patient has adequate hepatic function, as defined by the following criteria:
The patient has adequate renal function, as defined by the following criteria:
The patient has a baseline international normalized ratio (INR) < 1.5.
The patient, if a woman of childbearing potential, has a negative pregnancy test.
The patient is able to give written informed consent.
The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans.
Patients with early stage HCC may be included in the protocol to receive DEBDOX-M1 prior to resection
EXCLUSION CRITERIA:
The patient has a history of another primary cancer (ie, a primary cancer not associated with the patient's current liver tumor), with the exception of (a) curatively resected nonmelanomatous skin cancer; (b) curatively treated cervical carcinoma in situ; or (c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to enrollment (date of informed consent).
The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, targeted therapy, or an investigational agent.
The patient has extrahepatic, metastatic, symptomatic HCC. Enlarged reactive lymph nodes, or indeterminate lesions, such as lung nodules are acceptable.
The patient's tumor has replaced >70% of the liver volume.
The patient has clinically significant ascites. Trace ascites on imaging is acceptable.
Marco-shunting noted on the hepatic angiogram.
The patient has untreatable bleeding diathesis.
The patient has complete main portal vein thrombosis with reversal of flow.
The patient has a left ventricle ejection fraction of less than 45%.
The patient has evidence of clinically significant peripheral vascular disease.
The patient has clinically significant or symptomatic extrahepatic disease, for example, an uncontrolled inter-current illness including, but not limited to:
There is evidence of substance abuse or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
The patient is pregnant or breast-feeding.
The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
The patient has extra-hepatic, metastatic, and symptomatic HCC.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Geschwind, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
Not provided
The study enrolled patients diagnosed with unresectable hepatocellular carcinoma without prior locoregional therapy or concurrent anticancer therapy. Patients were enrolled from February 2014 to January 2015, with the last patient completing follow-up in August 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DEBDOX | DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | DEBDOX | DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Success of DEBDOX-M1 Procedure as a Measure of Feasibility | Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma. | The 24 patients received a total of 50 DEBDOX-M1 TACE procedures. | Posted | Number | percentage of successful treatments | 6 months | DEBDOX-M1 treatments | DEBDOX-M1 treatments |
|
Adverse events collected over the participant's duration on study (6 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEBDOX | DEBDOX: DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Francois Geschwind, MD | Yale University | 203-785-5865 | jeff.geschwind@yale.edu |
Not provided
| 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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Not provided
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Not provided
|
| 1 month |
| Efficacy - Tumor Response by qEASL | Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions. Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease. Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions. | 1 month |
| Efficacy - Tumor Response by mRECIST | Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD. | 1 month |
| Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions | The number of patients who underwent a liver transplantation following treatment on this protocol. | 6 months |
| AFP Tumor Marker Pre- and Post-treatment | The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure. | 1 month |
| 24 hours |
| Exploratory Endpoint - Total Drug Exposure Over Time (AUC) of Doxorubicin and Doxorubicinol Post TACE | Total drug exposure over time (AUC) of doxorubicin and its metabolite doxorubicinol post DEBDOX in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin.. | 24 hours |
| Exploratory Endpoint - Tmax of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE | Time taken to reach maximum concentration (Tmax) of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin.. | 24 hours |
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Out of 24 enrolled participants, 23 participants identified as non-Hispanic and 1 did not elect to reveal their ethnicity. From the 24 participants, 15 were white, 7 were black or African American, 1 was Asian, and 1 was unknown. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Collection of Adverse Events Related to Study Device as a Measure of Safety | For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE. | 30-day toxicity report of device-related adverse events for all 24 patients with classification and grading based on CTCAE v4.0. | Posted | Number | Adverse Events | 1 month |
|
|
|
| Secondary | Efficacy - Tumor Response by EASL | Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments. Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference. Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1. Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1. Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Efficacy - Tumor Response by qEASL | Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions. Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease. Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Efficacy - Tumor Response by mRECIST | Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments. Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD. | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions | The number of patients who underwent a liver transplantation following treatment on this protocol. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | AFP Tumor Marker Pre- and Post-treatment | The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure. | 23 out of 24 patients analyzed due to one patient not completing AFP post-TACE. | Posted | Mean | Full Range | ng/mL | 1 month |
|
|
|
|
| Other Pre-specified | Exploratory Endpoint - Pharmacokinetic (PK) Profile of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE | PK analysis of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin. | Posted | Mean | Standard Deviation | ng/mL | 24 hours |
|
|
|
| Other Pre-specified | Exploratory Endpoint - Total Drug Exposure Over Time (AUC) of Doxorubicin and Doxorubicinol Post TACE | Total drug exposure over time (AUC) of doxorubicin and its metabolite doxorubicinol post DEBDOX in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin.. | Posted | Mean | Standard Deviation | ng*h/mL | 24 hours |
|
|
|
| Other Pre-specified | Exploratory Endpoint - Tmax of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE | Time taken to reach maximum concentration (Tmax) of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin.. | Posted | Mean | Standard Deviation | minutes | 24 hours |
|
|
|
| 1 |
| 24 |
| 4 |
| 24 |
| 24 |
| 24 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intrahepatic biloma | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin abscess | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| Unknown |
|
| Title | Measurements |
|---|
|
| Fever |
|
| Weight loss |
|
| Weight gain |
|
| Insomnia |
|
| Hyperglycemia |
|
| Hypoglycemia |
|
| Ascites |
|
| Diarrhea |
|
| Constipation |
|
| Gas |
|
| Nausea/Vomiting |
|
| Groin hematoma |
|
| Hyperbilirubinemia |
|
| Hypoalbuminemia |
|
| Cellulitis |
|
| Headache |
|
| Confusion |
|
| Abdominal non-specific pain |
|
| Pain - general |
|
| Pain - right shoulder |
|
| Hypercreatininemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Grade 3 Elevated Transaminase |
|
| Hypoxia |
|
| Cardiac arrest |
|
| Total Grade 1-2 adverse events |
|
| Total Grade 3 or higher adverse events |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Objective response (CR + PR) |
|
| Disease control rate (CR + PR + SD) |
|