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

Primary Purpose

Liver Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Microwave ablation

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring hepatocellular carcinoma, microwave ablation, liver cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm.
Have at least one, but less than or equal to 3 tumors.
Each tumor must be ≤ 5 cm in diameter.
Child-Pugh class A-B.
Eastern Cooperative Oncology Group (ECOG) score of 0-1.
American Society of Anaesthesiologists (ASA) score ≤ 3.
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.
The disease status is not suitable to receive transarterial chemoembolization or other standard treatment.
Prior Informed Consent Form.
Life expectancy of at least 3 months.

Exclusion Criteria:

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave ablation (MWA)

Arm Description

Microwave ablation (MWA)

Outcomes

Primary Outcome Measures

tumor evaluation

Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).

Secondary Outcome Measures

Eastern Cooperative Oncology Group (ECOG) evaluation

Complete an Eastern Cooperative Oncology Group (ECOG) evaluation

Clinical laboratory assessment

Collect blood sample for hematology evaluation

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.

Review concomitant medications

Use of medications will be reviewed and recorded

Assess for presence of adverse events

An adverse event assessment will be performed

Full Information

NCT ID

NCT03063840

First Posted

January 4, 2017

Last Updated

November 18, 2020

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03063840

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Withdrawn

Why Stopped

NO participants enrolled

Study Start Date

July 2016 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer

Keywords

hepatocellular carcinoma, microwave ablation, liver cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microwave ablation (MWA)

Arm Type

Experimental

Arm Description

Microwave ablation (MWA)

Intervention Type

Device

Intervention Name(s)

Microwave ablation

Intervention Description

Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator

Primary Outcome Measure Information:

Title

tumor evaluation

Description

Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).

Time Frame

1 month after treatment

Secondary Outcome Measure Information:

Title

Eastern Cooperative Oncology Group (ECOG) evaluation

Description

Complete an Eastern Cooperative Oncology Group (ECOG) evaluation

Time Frame

up to two years

Title

Clinical laboratory assessment

Description

Collect blood sample for hematology evaluation

Time Frame

up to two years

Title

Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation

Description

Subjects will still be followed-up in the event of disease progression in order to document local recurrence.

Time Frame

up to two years

Title

Review concomitant medications

Description

Use of medications will be reviewed and recorded

Time Frame

up to two years

Title

Assess for presence of adverse events

Description

An adverse event assessment will be performed

Time Frame

up to two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 1 cm. Have at least one, but less than or equal to 3 tumors. Each tumor must be ≤ 5 cm in diameter. Child-Pugh class A-B. Eastern Cooperative Oncology Group (ECOG) score of 0-1. American Society of Anaesthesiologists (ASA) score ≤ 3. 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. The disease status is not suitable to receive transarterial chemoembolization or other standard treatment. Prior Informed Consent Form. Life expectancy of at least 3 months. Exclusion Criteria: Patients presenting with any of the following will not be enrolled into this study: Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception. Received treatment with an investigational agent/ procedure within 30 days prior to microwave ablation. Patients who cannot tolerate radiofrequency ablation (RFA) procedure. Known history of human immunodeficiency virus (HIV) infection. Concurrent extrahepatic cancer.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kai-Wen Huang, PhD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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