Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02343835|
Recruitment Status : Recruiting
First Posted : January 22, 2015
Last Update Posted : March 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Device: NanoKnife LEDC System||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IRE: Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2020|
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
- Characterization of the intra-tumoral and systemic immune response to IRE in unresectable pancreatic cancers [ Time Frame: 12 Months ]
- Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated pancreatic cancer
- Determine morphology and histology of regional lymph node after IRE
- 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)
- Comparison immune response between non-ablated and ablated pancreatic cancer and pre-ablated and post ablated serum [ Time Frame: 24 Months ]
- Compare serum cytokine and chemokine expression (in IU) between patients undergoing or not undergoing tumor ablation
- Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time
- 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.
- Overall survival and (local and distant) progression-free survival. [ Time Frame: 60 Months ]
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
|Contact: Lizhi l Niu, PHDfirstname.lastname@example.org|
|Contact: Feng l Jiang, M.Demail@example.com|
|FUDA Cancer Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510665|
|Contact: Lizhi Niu, M.D.,PHD. 8615989278151 firstname.lastname@example.org|
|Contact: feng jiang, M.D. 8615989278151 email@example.com|
|Study Chair:||Lizhi l Niu, M.D.,PHD.||FUDA Cancer Hospital|