TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02704130
• Other study ID #: 01-16-23B
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival		1 year
Secondary	Intrahepatic Disease-free Survival - 1 Year		1 year
Secondary	Postoperative Morbidity		1 month
Secondary	Postoperative Mortality		Assessed at 1 month and 3 months, total number up to 3 months reported
Secondary	Overall Survival		2 Years
Secondary	Overall Survival - 3 Years		3 Years
Secondary	Overall Survival - 5 Year		5 Years
Secondary	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
Secondary	Intrahepatic Disease-free Survival - 3 Year		3 Year
Secondary	Intrahepatic Disease-free Survival - 5 Year		5 Year
Secondary	Postoperative Morbidity		3 Month