Clinical trial NCT02704130: TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma
Official title: Transarterial Embolization and Microwave Ablation Combination Therapy in Early-stage Hepatocellular Carcinoma: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intrahepatic Disease-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 1 year
measure: Intrahepatic Disease-free Survival - 1 Year
timeFrame: 1 year
measure: Postoperative Morbidity
timeFrame: 1 month
measure: Postoperative Mortality
timeFrame: Assessed at 1 month and 3 months, total number up to 3 months reported
measure: Overall Survival
timeFrame: 2 Years
measure: Overall Survival - 3 Years
timeFrame: 3 Years
measure: Overall Survival - 5 Year
timeFrame: 5 Years
measure: Intrahepatic Disease-free Survival - 2 Year
timeFrame: 2 Year
measure: Intrahepatic Disease-free Survival - 3 Year
timeFrame: 3 Year
measure: Intrahepatic Disease-free Survival - 5 Year
timeFrame: 5 Year
measure: Postoperative Morbidity
timeFrame: 3 Month
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Dionisios Vrochides, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: