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Trial record 78 of 2838 for:    Pancreatic Cancer

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 : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: irreversible electroporation Drug: chemotherapy:Gemcitabine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Application of IRE Combined With Chemotherapy in the Treatment of Pancreatic Cancer
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IRE+chemo
irreversible electroporation with chemotherapy:Gemcitabine in pancreatic cancer
Procedure: irreversible electroporation
irreversible electroporation with chemotherapy in pancreatic cancer

Drug: chemotherapy:Gemcitabine
Intravenous infusion for 30 minutes
Other Name: Gemcitabine




Primary Outcome Measures :
  1. Safety (adverse effects) [ Time Frame: 6 month ]
    adverse effects


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02981719


Contacts
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Contact: Lizhi Niu, PHD 15521379041 735101262@qq.com

Locations
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China, Guangdong
FUDA Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Lizhi Niu, PHD    8615989278151    niuboshi@fudahospital.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PHD Fuda Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02981719     History of Changes
Other Study ID Numbers: Y2016-MS-001
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs