TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02704130
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma; Hepatoma; Liver Cancer, Adult; Liver Cell Carcinoma; Liver Cell Carcinoma, Adult	Device: Transarterial embolization; Procedure: Microwave Ablation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.; Other Names: TAE ; Procedure: 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.
Active Comparator: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Overall Survival [1 year]

2. Intrahepatic Disease-free Survival - 1 Year [1 year]

3. Postoperative Morbidity [1 month]

4. Postoperative Mortality [Assessed at 1 month and 3 months, total number up to 3 months reported]

5. Overall Survival [2 Years]

6. Overall Survival - 3 Years [3 Years]

7. Overall Survival - 5 Year [5 Years]

8. 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

9. Intrahepatic Disease-free Survival - 3 Year [3 Year]

10. Intrahepatic Disease-free Survival - 5 Year [5 Year]

11. Postoperative Morbidity [3 Month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Medical Center	Charlotte	North Carolina	United States	28204

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Dionisios Vrochides, MD PhD, Carolinas Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 28, 2016

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02704130
• Other Study ID Numbers: 01-16-23B
• First Posted: Mar 9, 2016
• Last Update Posted: Apr 22, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Wake Forest University Health Sciences: Therapeutic Embolization; Ablation Techniques; Transarterial Embolization; TAE; Microwave Ablation; MWA
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

Participant Flow

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	5	3
COMPLETED	0	0
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	5	3	8
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62.4	54.3	59.4
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	5 100%	3 100%	8 100%
Race/Ethnicity, Customized (Count of Participants)
White, non-Hispanic	5 100%	2 66.7%	7 87.5%
Hispanic	0 0%	0 0%	0 0%
Black or African American	0 0%	1 33.3%	1 12.5%
American Indian/Alaska Native	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
More Than One Race	0 0%	0 0%	0 0%
Unknown / Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%	3 100%	8 100%
BMI (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	29.414	28.57	28.99
Consented Participants (Count of Participants)
Count of Participants [Participants]	5 100%	3 100%	8 100%
Cirrhosis Present (Count of Participants)
Count of Participants [Participants]	5 100%	3 100%	8 100%
Ascites Present (Count of Participants)
Count of Participants [Participants]	4 80%	1 33.3%	5 62.5%
History of Hepatic Encephalopathy (Count of Participants)
Count of Participants [Participants]	3 60%	0 0%	3 37.5%
History of Ascites (Count of Participants)
Count of Participants [Participants]	4 80%	1 33.3%	5 62.5%
Please Note if any of the following are present (HCV, HPV, Heavy Alcohol use, drug use, nicotine use (Count of Participants)
Count of Participants [Participants]	4 80%	3 100%	7 87.5%
Please Note if any previous treatment occured (colon: ablation, tace, chemo, embolization, resection (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
Please note any previous antiviral therapy the patient has received (IFN, PEG-IFN, Harvon, Other) (Count of Participants)
Count of Participants [Participants]	2 40%	1 33.3%	3 37.5%
Method of diagnosis for HCC - CT (Count of Participants)
Count of Participants [Participants]	1 20%	0 0%	1 12.5%
Method of diagnosis for HCC - MRI (Count of Participants)
Count of Participants [Participants]	4 80%	3 100%	7 87.5%
Method of diagnosis for HCC - Biospy (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Intrahepatic Disease-free Survival
Description	Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

2. Secondary Outcome

Title	Overall Survival
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	5	3
Count of Participants [Participants]	4 80%	3 100%

3. Secondary Outcome

Title	Intrahepatic Disease-free Survival - 1 Year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	5	3
Count of Participants [Participants]	4 80%	3 100%

4. Secondary Outcome

Title	Postoperative Morbidity
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	5	3
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Postoperative Mortality
Time Frame	Assessed at 1 month and 3 months, total number up to 3 months reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	5	3
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Overall Survival
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

7. Secondary Outcome

Title	Overall Survival - 3 Years
Time Frame	3 Years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

8. Secondary Outcome

Title	Overall Survival - 5 Year
Time Frame	5 Years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

9. Secondary Outcome

Title	Intrahepatic Disease-free Survival - 2 Year
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

10. Secondary Outcome

Title	Intrahepatic Disease-free Survival - 3 Year
Time Frame	3 Year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

11. Secondary Outcome

Title	Intrahepatic Disease-free Survival - 5 Year
Time Frame	5 Year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	0	0

12. Secondary Outcome

Title	Postoperative Morbidity
Time Frame	3 Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAE + MWA Combination Therapy	MWA Monotherapy
Arm/Group Description	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.	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.
Measure Participants	5	3
Count of Participants [Participants]	1 20%	0 0%

Adverse Events

Time Frame	1 year, 10 months
Arm/Group Title	TAE + MWA Combination Therapy		MWA Monotherapy
Arm/Group Description	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.		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.
All Cause Mortality
	TAE + MWA Combination Therapy		MWA Monotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/5 (40%)		2/3 (66.7%)
Serious Adverse Events
	TAE + MWA Combination Therapy		MWA Monotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/5 (20%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Hypotensive	1/5 (20%)	1	1/3 (33.3%)	1
Other (Not Including Serious) Adverse Events
	TAE + MWA Combination Therapy		MWA Monotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/3 (0%)

Limitations/Caveats

Study closed early due to physician decision.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.