Liver Cancer
Conditions
Keywords
localized unresectable adult primary liver cancer, adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer
Brief summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: Primary * Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy. Secondary * Characterize the safety and toxicity of this regimen in these patients. * Determine the response rate in patients treated with this regimen. OUTLINE: Patients receive bevacizumab once in weeks 1, 3, and 5. Beginning in week 3, patients also receive transarterial chemoembolization (TACE) therapy. Treatment repeats approximately every 8 weeks for up to 3 courses. Patients achieving \< 100% necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventions
Sponsors
National Cancer Institute (NCI)
Northwestern University
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed\* hepatocellular carcinoma * Unresectable disease * Child's class A or B with liver-predominant and asymptomatic extrahepatic disease NOTE: \*A highly suspicious liver mass on CT scan or MRI in the presence of alpha fetoprotein \> 200 mg/dL may be used as alternative diagnostic criterion PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 50,000/mm³ * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5.0 times upper limit of normal (ULN) * Bilirubin ≤ 5.0 mg/dL * Creatinine normal OR creatinine clearance \> 50 mL/min * No significant traumatic injury within the past 28 days * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No serious, nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: * No major surgery or open biopsy within the past 28 days * No minor surgery (e.g., fine-needle aspirations or core biopsies) within the past 7 days * No chemotherapy within the past 4 weeks * No radiotherapy within the past 21 days * No concurrent major surgery * No other concurrent chemotherapy * No other concurrent investigational drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression-free Survival | Time through study completion, an average of 1 year | This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported. |
| Time to Tumor Progression (TTP) of Targeted Lesions | 6 months and 1 year | Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTP Rate at 6 Months and 1 Year | 6 months and 1 year | Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year |
| Overall Survival (OS) | 1 year | OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death. |
| Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | 6 months | Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD. |
| TTP of Nontargeted Lesions Within the Liver | 1 year | TTP of nontargeted lesions assessed via Kaplan-Meier methodology. |
| Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Cycle 1 pre-TACE - 2 weeks | Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy. |
| Safety and Treatment Toxicity - Cycle 1 Post-TACE | Cycle 1 post-TACE - 5 weeks | Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy |
| Safety and Treatment Toxicity - Cycles 2 and 3 | 6 months | Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy |
| Response Rate - Based on Tumor Enhancement | 6 months | Efficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria: Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression. |
| Overall TTP | 1 year | Overall TTP assessed via Kaplan-Meier methodology. |
Countries
United States
Participant flow
Recruitment details
Patients with a diagnosis of unresectable hepatocellular carcinoma (HCC) were enrolled on this protocol to receive a combination of intravenous bevacizumab and transarterial chemoembolization (TACE) therapy. A total of 26 patients were enrolled on protocol; 10 patients at Northwestern University and 16 at Johns Hopkins University.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm, Received Bevacizumab and TACE bevacizumab
chemotherapy
embolization therapy
hepatic artery infusion | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Single Arm, Received Bevacizumab and TACE |
|---|---|
| Age, Continuous | 64 years |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 26 |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 6 / 26 |
Outcome results
Primary
Median Progression-free Survival
This outcome was not assessed. Instead, the primary outcome of time to tumor progression (TTP) of the targeted lesions and secondary outcomes of TTP of nontargeted lesions and overall TTP were assessed and reported.
Time frame: Time through study completion, an average of 1 year
Population: PFS analysis was not conducted. No data were collected for this Outcome Measure
Primary
Time to Tumor Progression (TTP) of Targeted Lesions
Time to tumor progression was estimated via Kaplan-Meier methodology using the 23 patients who underwent treatment.
Time frame: 6 months and 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Time to Tumor Progression (TTP) of Targeted Lesions | NA months |
Secondary
Overall Survival (OS)
OS assessed via Kaplan-Meier methodology both from initiation of therapy and from the date of diagnosis until death.
Time frame: 1 year
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Overall Survival (OS) | OS from start of therapy | 10.8 months |
| Single Arm, Received Bevacizumab and TACE | Overall Survival (OS) | OS from date of diagnosis | 23.6 months |
Secondary
Overall TTP
Overall TTP assessed via Kaplan-Meier methodology.
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Overall TTP | 7.2 months |
Secondary
Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 3 weeks after TACE, and 4 weeks after completion of final cycle. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Partial Response (PR) | 8 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Stable Disease (SD) | 15 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Progressive Disease (PD) | 0 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Overall response rate (CR + PR) | 8 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Disease control rate (CR + PR + SD) | 23 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Response Evaluation Criteria in Solid Tumors (RECIST) | Complete Response (CR) | 0 Participants |
Secondary
Response Rate - Based on Tumor Enhancement
Efficacy as assessed by radiographic tumor response utilizing the following tumor enhancement criteria: Complete Response (CR): 100% tumor necrosis of the target lesion(s) upon completion of any of the 3 cycles of TACE therapy Partial Response (PR): Greater than 50% tumor necrosis of target lesion(s) Progressive Disease (PD): Reappearance or increased tumor enhancement greater than 25% in target lesion(s) Stable Disease (SD): Cases that do not meet CR or PR and did not demonstrate evidence of tumor progression.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Tumor Enhancement | Complete Response (CR) | 4 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Tumor Enhancement | Partial Response (PR) | 10 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Tumor Enhancement | Stable Disease (SD) | 9 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Tumor Enhancement | Progressive Disease (PD) | 0 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Tumor Enhancement | Overall response rate (CR + PR) | 14 Participants |
| Single Arm, Received Bevacizumab and TACE | Response Rate - Based on Tumor Enhancement | Disease control rate (CR + PR + SD) | 23 Participants |
Secondary
Safety and Treatment Toxicity - Cycle 1 Post-TACE
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for 25 who completed the first cycle of TACE and bevacizumab therapy
Time frame: Cycle 1 post-TACE - 5 weeks
Population: 1 out of the initial 26 patients did not complete the first TACE on protocol and was not included in this assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Nausea | 4 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Vomiting | 6 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | HEENT | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Elevated ALT | 7 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Elevated AST | 7 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Hyperbilirubinemia | 6 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Liver failure | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Cellulitis | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Colangitis | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Hyperglycemia | 8 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Hypocalcemia | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Hypokalemia | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Hyponatremia | 7 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Delirium | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Psychosis | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Abdominal pain, not otherwise specified (NOS) | 6 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Epigastric pain | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Right upper quadrant pain | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Chest pain | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Pain - other | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Dyspnea | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Acute renal failure | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Proteinuria | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Respiratory | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Anemia | 10 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Leukocytopenia | 7 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Lymphopenia | 8 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Edema | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Ischemia | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Coagulation | 10 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Fatigue | 12 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Night sweats | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Weight loss | 6 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Ascites | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Post-TACE | Anorexia | 11 adverse events |
Secondary
Safety and Treatment Toxicity - Cycle 1 Pre-TACE
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for all patients (n=26) who received bevacizumab prior to TACE therapy.
Time frame: Cycle 1 pre-TACE - 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Fatigue | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Weight loss | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Ascites | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Anorexia | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Nausea | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Vomiting | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Coagulation | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Esophageal varices | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Elevated ALT | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Elevated AST | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Hyperbilirubinemia | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Hyponatremia | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Encephalopathy | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Right upper quadrant pain | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Proteinuria | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycle 1 Pre-TACE | Respiratory | 1 adverse events |
Secondary
Safety and Treatment Toxicity - Cycles 2 and 3
Safety and toxicity assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3.0) for patients (n=14) who completed 2 or 3 cycles of TACE and bevacizumab therapy
Time frame: 6 months
Population: 14 out of the original 26 study participants completed 2 or 3 cycles of TACE and bevacizumab therapy - adverse events associated with these patients for cycles 2 and 3 assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Leukocytopenia | 7 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Lymphopenia | 12 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Heart failure | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Edema | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Coagulation | 5 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Fatigue | 11 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Weight loss | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Dermatologic | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Endocrine | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Ascites | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Anorexia | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Duodenal perforation | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Nausea | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Vomiting | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Hyperglycemia | 11 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Hypocalcemia | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Hypokalemia | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Stroke | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Right upper quadrant pain | 4 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Pain - other | 3 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Respiratory | 5 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Hyponatremia | 4 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Fracture | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Elevated ALT | 2 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Elevated AST | 6 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Hyperbilirubinemia | 4 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Clostridium difficile | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Cord compression | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Dyspnea | 1 adverse events |
| Single Arm, Received Bevacizumab and TACE | Safety and Treatment Toxicity - Cycles 2 and 3 | Proteinuria | 2 adverse events |
Secondary
TTP of Nontargeted Lesions Within the Liver
TTP of nontargeted lesions assessed via Kaplan-Meier methodology.
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm, Received Bevacizumab and TACE | TTP of Nontargeted Lesions Within the Liver | 9.1 months |
Secondary
TTP Rate at 6 Months and 1 Year
Overall TTP assessed via Kaplan-Meier methodology at 6 months and 1 year
Time frame: 6 months and 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm, Received Bevacizumab and TACE | TTP Rate at 6 Months and 1 Year | TTP rate at 6 months | 65 percentage of participants |
| Single Arm, Received Bevacizumab and TACE | TTP Rate at 6 Months and 1 Year | TTP rate at 1 year | 23 percentage of participants |