Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 2862 for:    Pancreatic Cancer AND pancreas

Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343835
Recruitment Status : Recruiting
First Posted : January 22, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
This protocol will study the impact of Irreversible electroporation (IRE) on immune response in patients diagnosed with unresectable pancreatic cancers smaller than 5.0 cm. It will profile the immune response to IRE of unresectable pancreatic cancers. The intra-tumoral and systemic immune response to IRE will be determined and compared to pre-ablated pancreatic cancer specimens and historical control specimens.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: NanoKnife LEDC System Not Applicable

Detailed Description:

Thirty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (≤5.0cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. Blood will be drawn for research before IRE. Blood and tissue samples will be used.

After IRE, patients will be carefully monitored and systemic immune responses are registered. Follow-up will consist of frequent CT and MRI scanning, as well as serum CA19.9 tumor marker and quality of life questionnaires and overall survival (OS).

The investigators hypothesize that IRE in the pancreas will induce good symptom palliation without causing severe complications as well as perfect systemic immune response.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: IRE: Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NanoKnife LEDC System
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
Device: NanoKnife LEDC System
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
Other Name: NanoKnife

No Intervention: Control
The patients without treatment



Primary Outcome Measures :
  1. Characterization of the intra-tumoral and systemic immune response to IRE in unresectable pancreatic cancers [ Time Frame: 12 Months ]
    1. Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated pancreatic cancer
    2. Determine morphology and histology of regional lymph node after IRE
    3. Quantify T cell response (IUs of IL2 and IFN gamma, and T cell specific cells as measured by number of spots on an elispot assay) to tumor associated antigens using in vitro assays of T cell proliferation and function (cytokine release, elispot, peptide-MHC)


Secondary Outcome Measures :
  1. Comparison immune response between non-ablated and ablated pancreatic cancer and pre-ablated and post ablated serum [ Time Frame: 24 Months ]
    1. Compare serum cytokine and chemokine expression (in IU) between patients undergoing or not undergoing tumor ablation
    2. Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time
    3. Compare intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated tumor tissue with paraffin embedded specimens for tumors that are matched for age, tumor size and histology.


Other Outcome Measures:
  1. Overall survival and (local and distant) progression-free survival. [ Time Frame: 60 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older 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): NCT02343835


Contacts
Layout table for location contacts
Contact: Lizhi l Niu, PHD 8615989278151 niuboshi@fudahospital.com
Contact: Feng l Jiang, M.D 8615989278151 niuboshi@fudahospital.com

Locations
Layout table for location information
China, Guangdong
FUDA Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Lizhi Niu, M.D.,PHD.    8615989278151    niuboshi@fudahospital.com   
Contact: feng jiang, M.D.    8615989278151    niuboshi@fudahospital.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
Layout table for investigator information
Study Chair: Lizhi l Niu, M.D.,PHD. FUDA Cancer Hospital

Layout table for additonal information
Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02343835     History of Changes
Other Study ID Numbers: JF-20150113(4)
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases