TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial

Conditions
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Hepatoma, Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult

Intervention / Treatment
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* Device: Transarterial embolization
* Procedure: Microwave Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAE + MWA combination therapy<br>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<br>* 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.<br>* Other names: TAE;Procedure: Microwave Ablation<br>* 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.<br>|
| Active Comparator: MWA monotherapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1 year | 
| 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 |  | 2 Years | 
| Overall Survival - 3 Years |  | 3 Years | 
| Overall Survival - 5 Year |  | 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 | 2 Year | 
| Intrahepatic Disease-free Survival - 3 Year |  | 3 Year | 
| Intrahepatic Disease-free Survival - 5 Year |  | 5 Year | 
| Postoperative Morbidity |  | 3 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAE, Therapeutic Embolization, Ablation Techniques, Transarterial Embolization, Microwave Ablation, MWA