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Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer

IRE: Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer

NCT02343835•Fuda Cancer Hospital, Guangzhou

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.

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+7 more criteria

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);
+9 more criteria

Locations (1)

FUDA Cancer Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

January 1, 2015

Primary Completion Date

December 1, 2020

Completion Date

May 1, 2021

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

NanoKnife LEDC System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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