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

NCT04044326 | Withdrawn DMC

• 1 other identifier: 201802047DIPB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

消融

Outcome Measures

Primary Outcomes (1)

• 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.

  up to one year

Secondary Outcomes (1)

• safety and local tumor recurrences

  within 30 days of treatment

Study Arms (1)

microwave ablation (MWA)

EXPERIMENTAL

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)

Procedure: The Solero Microwave Ablation

Interventions

The Solero Microwave Ablation PROCEDURE

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

microwave ablation (MWA)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, 100, Taiwan

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

Study Officials

• Kai-Wen Huang, MDPHD

  NTUH

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: microwave ablation

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: September 1, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 22, 2020
• Last Updated: September 14, 2020

Record last verified: 2019-08

Locations

TW (1)