A Clinical Research About Using Irreversible Electroporation to Treat Locally Advanced Pancreatic Cancer

NCT02841436 | Completed DMC

• 1 other identifier: 201210008DIC
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pancreatic cancers is one the most important malignancies with highest mortality in the world. The prognosis of these patients is very poor. Although some patients with early-diagnosed disease could receive surgical intervention, a majority (70%to 80%) of patients present with locally advanced or metastatic status are inoperable. Patients in this late status usually are recommended to receive palliative bypass operation such as choledochojejunostomy and/or gastrojejunostomy and palliative radiotherapy for the pancreatic cancer. Radiofrequency ablation (RFA) used to be expected an alternative therapy. However, the main drawback of RFA is its side effect to damage adjacent structure such as bile duct, and the tumors located adjacent to vessels could not be ablated well.

Conditions

Pancreatic Cancer

Keywords

irreversible electroporation; pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Tumor response will be evaluated by abdominal computed tomography (CT) or magnetic resonance imaging (MRI).

  1 month after treatment

Secondary Outcomes (6)

• Eastern Cooperative Oncology Group (ECOG) evaluation

  one to two years

• Haematology test

  one to two years

• Tumor marker measurement

  one to two years

• Conduct computed tomography (CT) or magnetic resonance imaging (MRI) scans for tumour response evaluation

  one to two years

• Review concomitant medications

  one to two years

Study Arms (1)

irreversible electroporation (IRE)

EXPERIMENTAL

IRE (AngioDynamics, NY) To use 2 to 6 unipolar electrodes 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:

• Locally advanced pancreatic cancer is defined as per the 7th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic cancer -described as arterial encasement of either the celiac axis or superior mesenteric artery or both.
• Biliary tract or intestine is compromised by tumor, palliative bypass operation (hepaticojejunostomy and/or gastrojejunostomy) is considered to be performed.
• 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 ≦ 5 mg/dL. alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal. prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 1.5 x upper limit of normal
• 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:
• 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
• Any active metal implanted device (eg Pacemaker),
• 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 treatment with the IRE System,
• Known history of human immunodeficiency virus (HIV) infection
• Patients with resectable lesions.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Electroporation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System 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 22, 2016
• Study Start: November 1, 2012
• Primary Completion: June 16, 2014
• Study Completion: May 27, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share