Pancreatic CancerNCT02343835
Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
A study testing NanoKnife LEDC System in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- NanoKnife LEDC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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;
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IRE: Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- NanoKnife LEDC System
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoKnife LEDC SystemDevice
Also called NanoKnife
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.
| Study group | Role | What they receive |
|---|---|---|
| NanoKnife LEDC System | Experimental | 90 pulses of 70 microseconds each in duration will be administered per electrode pair. Receives: Device: NanoKnife LEDC System |
| Control | No intervention | The patients without treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the intra-tumoral and systemic immune response to IRE in unresectable pancreatic cancers
- 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)
Measured: 12 Months
Secondary outcomes (1)
Comparison immune response between non-ablated and ablated pancreatic cancer and pre-ablated and post ablated serum
- 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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study start1 Jan 2015
- Primary completion1 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi l Niu, M.D.,PHD., Study chair, FUDA Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343835
- Sponsor's protocol ID
- JF-20150113(4)
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRE: Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02343835
- Acronym / sponsor ID
- JF-20150113(4)
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoKnife LEDC System | Experimental | Device: NanoKnife LEDC System90 pulses of 70 microseconds each in duration will be administered per electrode pair. |
| Control | No intervention | –The patients without treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (19 listed)
- 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:
- Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoKnife LEDC SystemAlso: NanoKnifeIrreversible 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. | Device | NanoKnife LEDC System |
Primary outcome
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)
1 secondary outcome
Comparison immune response between non-ablated and ablated pancreatic cancer and pre-ablated and post ablated serum
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizhi l Niu, M.D.,PHD. study chair
FUDA Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoKnife LEDC System in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the intra-tumoral and systemic immune response to IRE in unresectable pancreatic cancers (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.