Radiologically and histopathologically proven stage IV pancreatic cancer (according to the AJCC staging system for pancreatic cancer [52]). |
Brain metastases. |
Max. 5 unequivocal metastases ≥ 1 cm at the time of inclusion (i.e., after FOLFIRINOX). |
Active epilepsy (last convulsion < 5 years). |
Primary tumor is in situ. |
History of cardiac disease:
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Congestive heart failure > NYHA Class 2.
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Active coronary artery disease (defined as myocardial infarction within 6 months prior to screening).
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Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta-blockers for antihypertensive regimen are permitted; atrial fibrillation is not contra-indicated).
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A minimum of 8 cycles of FOLFIRINOX chemotherapy is required before study inclusion, with at least stable disease according to RECIST. |
Known hypersensitivity to any oligodeoxynucleotides. |
Age ≥ 18 years. |
Compromised liver function defined as warning signs of portal hypertension, INR > 1,5 without use of anticoagulants, bilirubin > × 1.5 Upper limit of normal range (ULN) ASAT > 3.0 × ULN, ALAT > 3.0 × ULN. |
World Health Organization (WHO) scale performance status 0–2. |
Compromised kidney function defined as eGFR < 30 mL/min (using the Cockcroft Gault formula). |
Adequate bile drainage in case of biliary obstruction. |
Active autoimmune disease requiring disease-modifying therapy at the time of screening, i.e., >10 mg prednisolone per day or equivalent to this regimen. |
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Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen. |
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Uncontrolled infections (>grade 2 NCI-CTC version 3.0) requiring antibiotics. |
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Immunotherapy prior to the procedure for the treatment of cancer. |
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Previous surgical therapy for pancreatic cancer. |
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Second primary malignancy with median 5-year OS < 90%. This excludes adequately treated cancers such as non-melanoma skin cancer, in situ carcinoma of the cervix uteri, superficial bladder cancer, or other malignancies that have been previously treated without signs of recurrence. |
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Allergy to contrast agent. |
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Allergy to PET tracers 18F-FDG and 18F-BMS-986192. |
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Any implanted stimulation device. |
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Portal vein or VMS stenosis > 70%, or any arterial stenosis (superior mesenteric artery, celiac artery, common hepatic artery) > 70% unless effectively stented. |
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Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study. |