Cancer of Liver
Conditions
Keywords
Hepatoma, Transcatheter Arterial chemo-embolization, Microsphere
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Radiopaque Microsphere (T-ACE Beads) interventional therapy for patients with liver cancer
Detailed description
The study will evaluate the safety and tolerability of Taiwan ACE Beads used for chemoembolization for the treatment of unresectable hepatocellular carcinoma. The investigators will study the overall response rates of lesions with Taiwan ACE Beads. The procedure is similar with conventional TACE (transcatheter arterial chemoembolization). At the target vessels, radiologists will inject lipiodol with doxorubicin first, then Taiwan ACE Beads instead of Gelfoam or PVA (polyvinyl alcohol). The end point of injection is also similar with conventional TACE. Determine the complication rates, progression free survival (PFS) and overall survival (OS) following Taiwan ACE Beads embolization.
Interventions
DEVICETaiwan ACE Beads
Similar with conventional TACE, radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
Sponsors
The Industrial Technology Research Institute
National Cheng Kung University
National Research Program for Biopharmaceuticals, Taiwan
National Cheng-Kung University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria in order to be entered into the study: A. Both genders of patients age 18 or older. B. Patients diagnosed of liver cancer (MUST meet at least ONE of the following criteria:) 1. Diagnosed via tumor biopsy by Pathologists, and confirmed by on-service physician. 2. High risk patients (Viral hepatitis B or C or cirrhotics) with typical liver cancer image appeared on more than two radiographic examinations (Ultrasound, MRI, CT scan or Angiography). 3. High risk patients (Viral hepatitis B or C cirrhotics) with evidence of enlarging image of liver cancer via more than two follow-up records. C. In intermediate stage by BCLC staging, tumor size between 3 to 6 centimeters, with liver function at Child-Pugh class\<9, and is either difficult to accept an operation or reluctant to accept any operation. D. Disease can be treated by transarterial chemoembolization, and can be evaluated by Ultrasound, Magnetic resonance imaging (MRI), or computed tomography (CT). E. Performance status ECOG 2 or less. Patient has a life expectancy of at least 3 months.
Exclusion criteria
If patients meet any of the following criteria they may not be entered into the study: A. major branch of portal vein has been invaded already; extrahepatic metastasis or the the other malignant tumors. B. Evidences of decompensation: Total Bilirubin\>2, PT prolong\>3 seconds, AST \> 500U/L, ALT\> 500U/L, Child-Pugh class≧9, refractory ascites, active bleeding, hepatic encephalopathy, and severe infection. C. Tumor size (diameter) larger than 6 centimeters or smaller than 3 centimeters. D. Cr\>2.0 mg/dL and eGFR\<50%. E. Allergic to iodine or other injections. F. Other main organ failure (Heart, Lung, or Kidney) G. WBC\<3000, ANC\<1500. H. Performance status ECOG of 3 or more. I. Unable to follow-up by ultrasound or CT scan. J. Unwilling to sign a written informed consent form. K. Pregnant women and breath feeding women. L. Patients whose blood vessel are too difficult to do Taiwan ACE Beads procedure. M. Prominent AV shunt. N. Severe atherosclerosis. O. Vasospasm or possible major vascular injury. P. Arteriovenous shunt patients, diameter larger than the size of microsphere available. Q. Collateral vascular exists and may endanger non-targeted area during arterial chemoembolization. R. Contraindications for doxorubicin. S. Number of tumors more than 3 and locate at different lobes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Survival (Safety) | An average of 12 weeks. | Survival rate was evaluated since treatment day until the date of death or final observation. |
| Tumor Response (Efficacy) | Before treatment, one month and three month after T-ACE using CT scan and MRI | mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Level of AFP | Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure | Serum Level of AFP \[Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure\] |
Countries
Taiwan
Participant flow
Recruitment details
The recruitment started in April, 2016. The location was all taken place in National Cheng Kung University Hospital. Patients who met inclusion criteria were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Hepatoma Treated Using Taiwan ACE Beads Clinical information of T-ACE beads H-series: Gender Male/Female 7/5, Age 71±8. The initial number of participants in the study was 13. However, one patient's blood test did not meet the standard before the operation, which led to his/her withdrawal from the clinical trial. Consequently, the total number of participants analyzed was 12. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Hepatoma Treated Using Taiwan ACE Beads |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 71 years STANDARD_DEVIATION 8 |
| Region of Enrollment Taiwan | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Patients Survival (Safety)
Survival rate was evaluated since treatment day until the date of death or final observation.
Time frame: An average of 12 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hepatoma Treated Using Taiwan ACE Beads | Patients Survival (Safety) | 12 Participants |
Primary
Tumor Response (Efficacy)
mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.
Time frame: Before treatment, one month and three month after T-ACE using CT scan and MRI
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Target Lesions | Complete Remission (CR) | 3 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Target Lesions | Partial Response (PR) | 4 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Target Lesions | Stable Disease (SD) | 3 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Target Lesions | Progressive Disease (PD) | 2 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Overall Response | Complete Remission (CR) | 2 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Overall Response | Partial Response (PR) | 3 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Overall Response | Stable Disease (SD) | 3 Participants |
| Hepatoma Treated Using Taiwan ACE Beads | Tumor Response (Efficacy) | Overall Response | Progressive Disease (PD) | 4 Participants |
Secondary
Serum Level of AFP
Serum Level of AFP \[Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure\]
Time frame: Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hepatoma Treated Using Taiwan ACE Beads | Serum Level of AFP | Baseline serum AFP levels | 168 ng/mL | Standard Deviation 383 |
| Hepatoma Treated Using Taiwan ACE Beads | Serum Level of AFP | one or three months of serum levels of AFP | 144 ng/mL | Standard Deviation 256 |