Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer

NCT02343835 | Completed DMC

• 1 other identifier: JF-20150113(4)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Characterization of the intra-tumoral and systemic immune response to IRE in unresectable pancreatic cancers

  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)

  12 Months

Secondary Outcomes (1)

• Comparison immune response between non-ablated and ablated pancreatic cancer and pre-ablated and post ablated serum

  24 Months

Other Outcomes (1)

• Overall survival and (local and distant) progression-free survival.

  60 Months

Study Arms (2)

NanoKnife LEDC System

EXPERIMENTAL

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Device: NanoKnife LEDC System

Control

NO INTERVENTION

The patients without treatment

Interventions

NanoKnife LEDC System DEVICE

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.

Also known as: NanoKnife

NanoKnife LEDC System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologic confirmation of unresectable pancreatic cancer by at least CT of chest and abdomen
• 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;
• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

FUDA Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Lizhi l Niu, M.D.,PHD.

  FUDA Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2019-02

Locations

CN (1)