TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

Not Applicable

Terminated

• Conditions: Liver Cancer, Adult; Hepatocellular Carcinoma; Liver Cell Carcinoma, Adult; Hepatoma; Liver Cell Carcinoma
• Interventions: Device: Transarterial embolization; Procedure: Microwave Ablation

• Registration Number: NCT02704130
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Results First Submitted: 2021-11-01
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-18
• Results First Posted: 2022-03-18
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAE + MWA combination therapy	Microwave Ablation	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.
MWA monotherapy	Microwave Ablation	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.
TAE + MWA combination therapy	Transarterial embolization	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.

Primary Outcome Measures

Name	Time	Method
Intrahepatic Disease-free Survival	2 years	Defined as the absence of local or regional recurrence of hepatocellular carcinoma (HCC) as determined by diagnostic imaging

Secondary Outcome Measures

Name	Time	Method
Intrahepatic Disease-free Survival - 3 Year	3 Year
Postoperative Morbidity	3 Month
Postoperative Mortality	Assessed at 1 month and 3 months, total number up to 3 months reported
Overall Survival	2 Years
Intrahepatic Disease-free Survival - 1 Year	1 year
Overall Survival - 3 Years	3 Years
Intrahepatic Disease-free Survival - 5 Year	5 Year
Overall Survival - 5 Year	5 Years
Intrahepatic Disease-free Survival - 2 Year	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

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States