Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
Conditions
Keywords
Therapeutic Embolization, Ablation Techniques, Transarterial Embolization, TAE, Microwave Ablation, MWA
Brief summary
This is a single-center, prospective RCT to study the effectiveness of TACE and MWA combination therapy with MWA monotherapy for the treatment of early HCC. Primary outcome is 2-year intrahepatic disease-free survival.
Detailed description
This single-center, prospective randomized controlled trial (RCT) is designed to compare the outcomes and clinicopathologic results of trans arterial embolization (TAE) and microwave ablation (MWA) combination therapy with MWA monotherapy for the treatment of early (stages 0 and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test the following hypothesis: 2-year intrahepatic disease-free survival does not differ between patients receiving the experimental therapy (MWA + TAE) and patients receiving the standard therapy (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine the clinical feasibility of TAE + MWA in HCC patients with a small tumor burden using patient demographics and disease characteristic data and 2) to determine the effect of TAE on radiographic tumor characteristics in this patient cohort. The primary outcome is 2-year intrahepatic disease-free survival, which is measured from time of randomization and is defined as the absence of local or regional recurrence of HCC as determined by diagnostic imaging. Local recurrence is defined as an enhancing lesion contiguous with the ablation zone that is present on subsequent imaging but was not present on the initial post-ablation scan. Regional recurrence is defined as hepatic recurrence that is not adjacent to the ablation site.
Interventions
In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.
PROCEDUREMicrowave Ablation
Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of hepatocellular carcinoma (HCC) * HCC classification of stage 0 (very early) or stage A (early) according to Barcelona Clinic Liver Cancer (BCLC) staging system criteria * Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic transarterial embolization (TAE) and/or microwave ablation (MWA) as treatment for HCC * Willing and able to give informed consent
Exclusion criteria
* Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases * Evidence of residual disease at first post-MWA computed tomography examination * Body Mass Index (BMI) \> 35 * Previous history of hepatic resections * Severe renal dysfunction (creatinine clearance of \<40 mL/min) * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrahepatic Disease-free Survival | 2 years | Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrahepatic Disease-free Survival - 1 Year | 1 year | — |
| Postoperative Morbidity | 1 month | — |
| Postoperative Mortality | Assessed at 1 month and 3 months, total number up to 3 months reported | — |
| Overall Survival - 3 Years | 3 Years | — |
| Overall Survival | 1 year | — |
| Intrahepatic Disease-free Survival - 2 Year | 2 Year | Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) from date of treatment until 2 years after that date as determined by diagnostic imaging |
| Intrahepatic Disease-free Survival - 3 Year | 3 Year | — |
| Intrahepatic Disease-free Survival - 5 Year | 5 Year | — |
| Overall Survival - 5 Year | 5 Years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAE + MWA Combination Therapy In patients randomized to receive the experimental therapy, transarterial embolization (TAE) treatments will be initiated within one week of randomization. Blunt embolization will be performed with LC beads with a maximum size of 700 µm. Microwave ablation (MWA) will be performed up to one month following randomization. The LC beads will be admixed with 8-15 mL of contrast and injected into the arterial branch at a rate of 1-2 mL/min. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request.
Transarterial embolization: In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.
Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors. | 5 |
| MWA Monotherapy Microwave ablation (MWA) will be performed up to one month following randomization. Treatment may be discontinued if any exclusion criteria develop in the patient or at the patient's request. All operative MWAs will be performed in a laparoscopic or robot-assisted laparoscopic setting. All ablations will be guided by intraoperative ultrasound. Ablations will be performed with a 2.45-GHz generator with a 1.8-mm-diameter transcutaneous antenna.
Microwave Ablation: Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors. | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 3 |
Baseline characteristics
| Characteristic | MWA Monotherapy | Total | TAE + MWA Combination Therapy |
|---|---|---|---|
| Age, Continuous | 54.3 years | 59.4 years | 62.4 years |
| Ascites Present | 1 Participants | 5 Participants | 4 Participants |
| BMI | 28.57 kg/m^2 | 28.99 kg/m^2 | 29.414 kg/m^2 |
| Cirrhosis Present | 3 Participants | 8 Participants | 5 Participants |
| Consented Participants | 3 Participants | 8 Participants | 5 Participants |
| History of Ascites | 1 Participants | 5 Participants | 4 Participants |
| History of Hepatic Encephalopathy | 0 Participants | 3 Participants | 3 Participants |
| Method of diagnosis for HCC - Biospy | 0 Participants | 0 Participants | 0 Participants |
| Method of diagnosis for HCC - CT | 0 Participants | 1 Participants | 1 Participants |
| Method of diagnosis for HCC - MRI | 3 Participants | 7 Participants | 4 Participants |
| Please note any previous antiviral therapy the patient has received (IFN, PEG-IFN, Harvon, Other) | 1 Participants | 3 Participants | 2 Participants |
| Please Note if any of the following are present (HCV, HPV, Heavy Alcohol use, drug use, nicotine use | 3 Participants | 7 Participants | 4 Participants |
| Please Note if any previous treatment occured (colon: ablation, tace, chemo, embolization, resection | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized More Than One Race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown / Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 2 Participants | 7 Participants | 5 Participants |
| Region of Enrollment United States | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 5 | 2 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 3 |
| serious Total, serious adverse events | 1 / 5 | 0 / 3 |
Outcome results
Primary
Intrahepatic Disease-free Survival
Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging
Time frame: 2 years
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Intrahepatic Disease-free Survival - 1 Year
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAE + MWA Combination Therapy | Intrahepatic Disease-free Survival - 1 Year | 4 Participants |
| MWA Monotherapy | Intrahepatic Disease-free Survival - 1 Year | 3 Participants |
Secondary
Intrahepatic Disease-free Survival - 2 Year
Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) from date of treatment until 2 years after that date as determined by diagnostic imaging
Time frame: 2 Year
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Intrahepatic Disease-free Survival - 3 Year
Time frame: 3 Year
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Intrahepatic Disease-free Survival - 5 Year
Time frame: 5 Year
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Overall Survival
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAE + MWA Combination Therapy | Overall Survival | 4 Participants |
| MWA Monotherapy | Overall Survival | 3 Participants |
Secondary
Overall Survival
Time frame: 2 Years
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Overall Survival - 3 Years
Time frame: 3 Years
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Overall Survival - 5 Year
Time frame: 5 Years
Population: The analysis population description is not available. This study was terminated 1 year and 10 months after the enrollment of the first patient. There was not enough funding the support this study, and the PI opted to terminate the study.
Secondary
Postoperative Morbidity
Time frame: 3 Month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAE + MWA Combination Therapy | Postoperative Morbidity | 1 Participants |
| MWA Monotherapy | Postoperative Morbidity | 0 Participants |
Secondary
Postoperative Morbidity
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAE + MWA Combination Therapy | Postoperative Morbidity | 0 Participants |
| MWA Monotherapy | Postoperative Morbidity | 0 Participants |
Secondary
Postoperative Mortality
Time frame: Assessed at 1 month and 3 months, total number up to 3 months reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAE + MWA Combination Therapy | Postoperative Mortality | 0 Participants |
| MWA Monotherapy | Postoperative Mortality | 0 Participants |