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. 2021 Aug 2;13(15):3902. doi: 10.3390/cancers13153902

Table 1.

In- and exclusion criteria PANFIRE-III.

Inclusion Exclusion
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:
  • Congestive heart failure > NYHA Class 2.

  • Active coronary artery disease (defined as myocardial infarction within 6 months prior to screening).

  • Ventricular cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta-blockers for antihypertensive regimen are permitted; atrial fibrillation is not contra-indicated).

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.
Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen.
Uncontrolled infections (>grade 2 NCI-CTC version 3.0) requiring antibiotics.
Immunotherapy prior to the procedure for the treatment of cancer.
Previous surgical therapy for pancreatic cancer.
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.
Allergy to contrast agent.
Allergy to PET tracers 18F-FDG and 18F-BMS-986192.
Any implanted stimulation device.
Portal vein or VMS stenosis > 70%, or any arterial stenosis (superior mesenteric artery, celiac artery, common hepatic artery) > 70% unless effectively stented.
Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.