TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

NCT02704130 | Terminated Results DMC FDA Device

• 1 other identifier: 01-16-23B
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

TAE + MWA combination therapy

EXPERIMENTAL

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; Procedure: Microwave Ablation

MWA monotherapy

ACTIVE COMPARATOR

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

Interventions

Transarterial embolization DEVICE

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.

Also known as: TAE

TAE + MWA combination therapy

Microwave Ablation PROCEDURE

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.

MWA monotherapy; TAE + MWA combination therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

Study closed early due to physician decision.

Results Point of Contact

• Title: Blair Stephenson, Research Business Manager
• Organization: Atrium Health

blair.stephenson@atriumhealth.org

704-446-4845

Study Officials

• Dionisios Vrochides, MD PhD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 22, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)