Hepatocellular CarcinomaNCT02704130
TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma
A study testing Transarterial embolization and Microwave Ablation in people with Hepatocellular Carcinoma and Hepatoma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult
- What is being tested?
- Transarterial embolization and Microwave Ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28204
About this study
Official title: Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
- Being tested
- Transarterial embolization, Microwave Ablation
- Keywords
- Therapeutic Embolization, Ablation Techniques, Transarterial Embolization, TAE, Microwave Ablation, MWA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial embolizationDevice
Also called TAE
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 AblationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TAE + MWA combination therapy | Experimental | 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. Receives: Device: Transarterial embolization; Procedure: Microwave Ablation |
| MWA monotherapy | Active comparator | 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. Receives: Procedure: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatic Disease-free Survival
Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging
Measured: 2 years
Secondary outcomes (11)
Overall Survival
Measured: 1 year
Intrahepatic Disease-free Survival - 1 Year
Measured: 1 year
Postoperative Morbidity
Measured: 1 month
Postoperative Mortality
Measured: Assessed at 1 month and 3 months, total number up to 3 months reported
Overall Survival
Measured: 2 Years
Overall Survival - 3 Years
Measured: 3 Years
Overall Survival - 5 Year
Measured: 5 Years
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
Measured: 2 Year
Intrahepatic Disease-free Survival - 3 Year
Measured: 3 Year
Intrahepatic Disease-free Survival - 5 Year
Measured: 5 Year
Postoperative Morbidity
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dionisios Vrochides, MD PhD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704130
- Sponsor's protocol ID
- 01-16-23B
- Status last verified
- Feb 2022
- First submitted
- 3 Mar 2016
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02704130
- Acronym / sponsor ID
- 01-16-23B
- Conditions
- Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
- Keywords
- Therapeutic Embolization, Ablation Techniques, Transarterial Embolization, TAE, Microwave Ablation, MWA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 18 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAE + MWA combination therapy | Experimental | Device: Transarterial embolization, Procedure: Microwave AblationIn 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. |
| MWA monotherapy | Active comparator | Procedure: Microwave AblationMicrowave 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial embolizationAlso: TAEIn 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. | Device | TAE + MWA combination therapy |
| Microwave AblationMicrowave 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. | Procedure or surgery | MWA monotherapy, TAE + MWA combination therapy |
Primary outcome
Intrahepatic Disease-free Survival
Time frame: 2 years
Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging
11 secondary outcomes
Overall Survival
Time frame: 1 year
Intrahepatic Disease-free Survival - 1 Year
Time frame: 1 year
Postoperative Morbidity
Time frame: 1 month
Postoperative Mortality
Time frame: Assessed at 1 month and 3 months, total number up to 3 months reported
Overall Survival
Time frame: 2 Years
Overall Survival - 3 Years
Time frame: 3 Years
Overall Survival - 5 Year
Time frame: 5 Years
Intrahepatic Disease-free Survival - 2 Year
Time frame: 2 Year
Intrahepatic Disease-free Survival - 3 Year
Time frame: 3 Year
Intrahepatic Disease-free Survival - 5 Year
Time frame: 5 Year
Postoperative Morbidity
Time frame: 3 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dionisios Vrochides, MD PhD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial embolization and Microwave Ablation in people with Hepatocellular Carcinoma and Hepatoma, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahepatic Disease-free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.