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Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02981719
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE October 31, 2016
First Posted Date  ICMJE December 5, 2016
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE October 1, 2016
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
Safety (adverse effects) [ Time Frame: 6 month ]
adverse effects
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02981719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
  • Efficacy (percentage of lesions that show no sign of recurrence 12 months after [ Time Frame: 12months ]
    The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)
  • Voltage (A minimum and maximum range of voltage for safe and effective IRE) [ Time Frame: 3 months ]
    A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
  • Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer
Official Title  ICMJE Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer
Brief Summary The aim of this study was to observe the survival status, recurrence and death time of patients with pancreatic cancer treated by chemotherapy combined with IRE. The survival and overall survival of the patients were evaluated respectively.
Detailed Description Irreversible electroporation (Irreversible Electroporation IRE) ablation as a new minimally invasive therapy in inhibiting tumor growth, improve survival rate and achieved remarkable results, and chemotherapy as traditional treatment methods,at the same time with adjuvant chemotherapy in ablation of irreversible electroporation can improve chemotherapy perforation area to the spread of cancer cells in reversibility, and has selectivity to tumor cells, avoiding normal tissue damage. The combination of the two aims to improve the quality of life and prolong the survival time. The aim of this study was to observe the survival status, recurrence and death time of patients with pancreatic cancer treated by chemotherapy combined with IRE. The survival and overall survival of the patients were evaluated respectively.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Procedure: irreversible electroporation
    irreversible electroporation with chemotherapy in pancreatic cancer
  • Drug: chemotherapy:Gemcitabine
    Intravenous infusion for 30 minutes
    Other Name: Gemcitabine
Study Arms  ICMJE Experimental: IRE+chemo
irreversible electroporation with chemotherapy:Gemcitabine in pancreatic cancer
Interventions:
  • Procedure: irreversible electroporation
  • Drug: chemotherapy:Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Radiologic confirmation of unresectable pancreatic cancer by at least CT of chest and abdomen
  • Screening must be performed no longer than 2 weeks prior to study inclusion
  • Maximum tumor diameter ≤ 5 cm
  • Histological or cytological confirmation of pancreatic adenocarcinoma;
  • Age ≥ 18 years
  • ASA-classification 0 - 3
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
  • Hemoglobin ≥ 5.6 mmol/L
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 100*109/l
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min
  • Prothrombin time or INR < 1.5 x ULN
  • Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician)
  • Written informed consent

Exclusion Criteria:

  • Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team
  • Successful down staging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor
  • History of epilepsy
  • History of cardiac disease:
  • Congestive heart failure >NYHA class 2
  • Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening)
  • Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
  • Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen
  • Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites)
  • Uncontrolled infections (> grade 2 NCI-CTC version 3.0)
  • Pregnant. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
  • Immunotherapy ≤ 6 weeks prior to the procedure
  • Chemotherapy ≤ 6 weeks prior to the procedure
  • Radiotherapy ≤ 6 weeks prior to the procedure
  • Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers used for antihypertensive)
  • Allergy to contrast media
  • Any implanted stimulation device
  • Any implanted metal stent/device within the area of ablation that cannot be removed
  • Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study; Of note, patients with contra-indications for MRI will not be excluded from participation: in this case radiologic follow-up will consist of CT-scanning according to protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lizhi Niu, PHD 15521379041 735101262@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02981719
Other Study ID Numbers  ICMJE Y2016-MS-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lizhi Niu, PHD Fuda Cancer Hospital
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP