A Clinical Trial Using Irreversible Electroporation for the Treatment of Liver Cancers

NCT02828865 | Completed DMC

• 1 other identifier: 201210007DIC
• Study Type: interventional
• Target: 18
• 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. 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.

Conditions

Hepatocellular Carcinoma; Metastatic Liver Cancers

Keywords

Hepatocellular Carcinoma; irreversible electroporation; liver cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Tumor response, according to modified RECIST criteria, will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI) 1 month after treatment.

  1 month after treatment

Secondary Outcomes (8)

• Change of Eastern Cooperative Oncology Group (ECOG) evaluation

  one to two years

• Change of vital signs

  one to two years

• Physical examination

  one to two years

• Clinical laboratory assessments

  one to two years

• Urinalysis

  one to two years

Study Arms (1)

irreversible electroporation (IRE)

EXPERIMENTAL

irreversible electroporation (IRE) (AngioDynamics, NY) To use 2 to 6 unipolar electrodes of IRE in a predetermined grid pattern. 90 pulses of 2,000 - 3,000 V were applied with a pulse generator (AngioDynamics, NY) across the gap between the electrodes for 100 microseconds (0.1 msec) per each ablation.

Device: Irreversible Electroporation (IRE) System

Interventions

Irreversible Electroporation (IRE) System DEVICE

irreversible electroporation (IRE)

Eligibility Criteria

• Age: 20 Years - 75 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 American Association for the Study of Liver Diseases (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 computed tomography (CT) scan or dynamic contrast enhanced magnetic resonance imaging (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 cluster of differentiation 34 (CD34), cytokeratin 7 (CK7), glypican 3, heat shock protein 70 (HSP70), and glutamine synthetase to improve diagnostic accuracy.
• Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and vessels is smaller than 5 mm.
• 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, liver and renal function. Platelet count ≥ 100 K/Μl. Total bilirubin ≦ 2 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0. Serum creatinine ≦ 1.5 x upper limit of normal
• Prior Informed Consent Form
• Life expectancy of at least 3 months.
• The disease status is not suitable to receive surgical resection, percutaneous alcohol injection, transarterial chemoembolization or other standard treatment.

You may not qualify if:

• Patients presenting with any of the following will not be enrolled into this study:
• \. History of cardiac disease:
• Congestive heart failure \>New York Heart Association (NYHA) class 2
• Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
• Cardiac arrhythmias (\>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
• Uncontrolled hypertension 2. Any active metal implanted device (eg Pacemaker), 3. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, 4. Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the IRE System, 5. Known history of HIV infection 6. Concurrent extrahepatic cancer

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Electroporation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Drug Therapy; Therapeutics

Study Officials

• Kai-Wen Huang, PhD

  National Taiwan University Hospital

  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

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 12, 2016
• Study Start: November 1, 2012
• Primary Completion: December 18, 2013
• Study Completion: May 27, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)