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

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ClinicalTrials.gov Identifier: NCT03063840
Recruitment Status : Unknown
Verified January 2017 by National Taiwan University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
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. 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Device: Microwave ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Safety and Efficacy of Microwave Ablation for the Treatment of Malignant
Study Start Date : July 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Microwave ablation (MWA)
Microwave ablation (MWA)
Device: Microwave ablation
Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator




Primary Outcome Measures :
  1. tumor evaluation [ Time Frame: 1 month after treatment ]
    Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).


Secondary Outcome Measures :
  1. Eastern Cooperative Oncology Group (ECOG) evaluation [ Time Frame: up to two years ]
    Complete an Eastern Cooperative Oncology Group (ECOG) evaluation

  2. Clinical laboratory assessment [ Time Frame: up to two years ]
    Collect blood sample for hematology evaluation

  3. Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation [ Time Frame: up to two years ]
    Subjects will still be followed-up in the event of disease progression in order to document local recurrence.

  4. Review concomitant medications [ Time Frame: up to two years ]
    Use of medications will be reviewed and recorded

  5. Assess for presence of adverse events [ Time Frame: up to two years ]
    An adverse event assessment will be performed



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063840


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kai-Wen Huang, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03063840     History of Changes
Other Study ID Numbers: 201603095DIPD
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Taiwan University Hospital:
hepatocellular carcinoma
microwave ablation
liver cancer

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases