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

Not Applicable

Withdrawn

• Conditions: Hepatocellular Carcinoma (HCC)
• Interventions: Procedure: The Solero Microwave Ablation

• Registration Number: NCT04044326
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Study Start: 2019-09-01
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-22
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microwave ablation (MWA)	The Solero Microwave Ablation	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)

Primary Outcome Measures

Name	Time	Method
the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria	up to one year	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

Name	Time	Method
safety and local tumor recurrences	within 30 days of treatment	The safety endpoint will be treatment-related Serious Adverse Events occurring within 30 days of treatment.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Test2, Taiwan