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The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status

Withdrawn

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

The Solero Microwave Ablation

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring 消融

Eligibility Criteria

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

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

The diagnosis of hepatocellular carcinoma (HCC) or metastatic liver cancers with pathologic proven, and the diagnosis of HCC will be made by pathology / cytology or according to the AASLD(2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either tri-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and inferior vena cava 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 ≦ 3 mg/dL(3). ALT and AST < 5 x upper limit of normal (4). PT-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 RFA procedure, including the patients have tumors closed to gall bladder, pancreas, liver hilum and main bile ducts
Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney, and the patients with metallic implantation including pacemaker.
Known history of HIV infection
Concurrent extrahepatic cancer

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

microwave ablation (MWA)

Arm Description

20 patients with liver cancer, considered for local treatment of liver tumors of size measuring <5 cm and without any signs of extra-hepatic metastasis, will be enrolled to be treated with microwave ablation (MWA)

Outcomes

Primary Outcome Measures

the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria

The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed 1 month after treatment.

Secondary Outcome Measures

safety and local tumor recurrences

The safety endpoint will be treatment-related Serious Adverse Events occurring within 30 days of treatment.

Full Information

NCT ID

NCT04044326

First Posted

August 1, 2019

Last Updated

September 10, 2020

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04044326

Brief Title

The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors

Official Title

The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Inferior Vena Cava

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Machine cannot provide

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

January 6, 2020 (Actual)

Study Completion Date

January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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. Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, the researchers will perform MWA for 20 inoperable patients with liver cancers adjacent to inferior vena cava (IVC). The researchers will appraisal the clinical feasibility and advantage of the system by this study.

Detailed Description

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 location. The tumors located adjacent to big vessels such as inferior vena cava (IVC), 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. Several pre-clinical studies have already demonstrated MWA is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE mark and FDA approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 20 inoperable patients with liver cancers adjacent to IVC in our hospital. The researchers will evaluate the potential side effect and ablate effect of tumors by abdominal CT or MRI, and the researchers will also follow-up this patients for 4 months to evaluate the complete ablation rate and local recurrence rate. We 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

Hepatocellular Carcinoma (HCC)

Keywords

消融

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

microwave ablation

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

Intervention Type

Procedure

Intervention Name(s)

The Solero Microwave Ablation

Intervention Description

The Solero Microwave Ablation system (Angiodynamics Ltd, USA) with a single microwave applicator operating at a 2.45 GHz will be used to perform MWA

Primary Outcome Measure Information:

Title

the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria

Description

The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed 1 month after treatment.

Time Frame

up to one year

Secondary Outcome Measure Information:

Title

safety and local tumor recurrences

Description

The safety endpoint will be treatment-related Serious Adverse Events occurring within 30 days of treatment.

Time Frame

within 30 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Patients must meet all of the following inclusion criteria to be eligible for this study: The diagnosis of hepatocellular carcinoma (HCC) or metastatic liver cancers with pathologic proven, and the diagnosis of HCC will be made by pathology / cytology or according to the AASLD(2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either tri-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy. Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and inferior vena cava 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 ≦ 3 mg/dL(3). ALT and AST < 5 x upper limit of normal (4). PT-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 RFA procedure, including the patients have tumors closed to gall bladder, pancreas, liver hilum and main bile ducts Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney, and the patients with metallic implantation including pacemaker. Known history of HIV infection Concurrent extrahepatic cancer

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kai-Wen Huang, MDPHD

Organizational Affiliation

NTUH

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

State/Province

Test2

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors

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