Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Intrahepatic Vessels

To Evaluate the Safety and Efficacy of Microwave Ablation for the Treatment of Malignant

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely sometimes. Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels.

Study Overview

• Status: Withdrawn
• Conditions: Liver Cancer
• Intervention / Treatment: Device: Microwave ablation

Detailed Description

Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Emprint Microwave Ablation system) with 2.45 GHz microwave generator the investigators will use has been approved as safe by the European Union (EU) in 2009 and received Food and Drug Administration (FDA) approval in 2014. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 40 inoperable patients with liver cancers adjacent to vessels who are suitable to receive radiofrequency ablation (RFA) in our hospital. The investigators will evaluate the potential side effect and ablate effect of tumors by abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators will also follow-up this patients for 1 years to evaluate the overall survival and local recurrence rate. The investigators will appraisal the clinical feasibility and advantage of the system by this study.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for this study:

1. Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm.
2. Have at least one, but less than or equal to 3 tumors.
3. Each tumor must be ≤ 5 cm in diameter.
4. Child-Pugh class A-B.
5. Eastern Cooperative Oncology Group (ECOG) score of 0-1.
6. American Society of Anaesthesiologists (ASA) score ≤ 3.
7. Adequate bone marrow and liver function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 2 mg/dL(3). alanine transaminase (ALT) and aspartate transaminase (AST) < 5 x upper limit of normal (4). prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0.
8. The disease status is not suitable to receive transarterial chemoembolization or other standard treatment.
9. Prior Informed Consent Form.
10. Life expectancy of at least 3 months.

Exclusion Criteria:

Patients presenting with any of the following will not be enrolled into this study:

1. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
2. Received treatment with an investigational agent/ procedure within 30 days prior to microwave ablation.
3. Patients who cannot tolerate radiofrequency ablation (RFA) procedure.
4. Known history of human immunodeficiency virus (HIV) infection.
5. Concurrent extrahepatic cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Microwave ablation (MWA)	Device: Microwave ablation; Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tumor evaluation	Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).	1 month after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eastern Cooperative Oncology Group (ECOG) evaluation	Complete an Eastern Cooperative Oncology Group (ECOG) evaluation	up to two years
Clinical laboratory assessment	Collect blood sample for hematology evaluation	up to two years
Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation	Subjects will still be followed-up in the event of disease progression in order to document local recurrence.	up to two years
Review concomitant medications	Use of medications will be reviewed and recorded	up to two years
Assess for presence of adverse events	An adverse event assessment will be performed	up to two years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ACTUAL): July 27, 2018

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: February 23, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; microwave ablation; liver cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 201603095DIPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO