TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma
| Status: | Terminated |
|---|---|
| Conditions: | Liver Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/1/2018 |
| Start Date: | March 2016 |
| End Date: | January 2018 |
Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial
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.
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.
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
We found this trial at
1
site
1000 Blythe Blvd
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Dionisios Vrochides, MD PhD
Phone: 704-446-4838
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