TTFields and Chemotherapy in Metastatic Pancreatic Adenocarcinoma (mPDAC)

Inclusion Criteria

• •All the patients should comply with the following criteria for inclusion:
• •1. Histological/cytological diagnosis of pancreatic adenocarcinoma.
• •2. The patient should be 18 years of age and older.
• •3. The patient has given consent to participate in the study.
• •4. The patient should be able to comply with all the requirements of the clinical trial.
• •5. Life expectancy of at least 3 months.
• •6. Metastatic disease with, at least, one hepatic lesion that must be accessible for biopsy.
• •7. Measurable disease as defined by Response Evaluation Criteria in Solid Tumor v1.1 (RECIST 1.1) apart from the liver lesion to be biopsied.
• •8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• •9. Amenable and assigned by the investigator to receive therapy with modFOLFIRINOX.
• •10. Prior chemotherapy or radiotherapy on the neoadjuvant or adjuvant setting is allowed as long as at least six months have elapsed since last chemotherapy treatment.
• •11. Able to operate the Novo TTF-200T System independently or with the help of a caregiver.
• •12. Adequate hematologic and organ function, defined by the following laboratory test results, obtained during the screening period and before C1D1.
• •1. WBC higher than or equal to 2.5 x 10\^9/L.
• •2. ANC higher than or equal to 1.5 x 10\^9/L without granulocyte colony-stimulating factor support.
• •3. Platelet count higher than or equal to 100 x 10\^9/L without transfusion.
• •4. Hemoglobin higher than or equal to 9 g/dL. Patients may be transfused to meet this criterion.
• •5. Albumin higher than or equal to 2.5 g/dL.
• •6. Serum bilirubin lower than or equal to 1.5 times the upper limit of normal (ULN); patients with known Gilbert´s disease may have a bilirubin value lower than or equal to 3 x ULN.
• •7. INR and aPTT lower than or equal to 1.5 x ULN.
• •8. AST, ALT, lower than or equal to 5 x ULN.
• •9. Serum creatinine lower than or equal to 1.5 x ULN or Creatinine Clearance higher than or equal to 30ml/min (calculated using Cockcroft-Gault formula).
• •13. For women of childbearing potential: Negative serum pregnancy test within 14 days prior to C1D1. Agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of lower than or equal to 1 percentage per year during the treatment period (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal o transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable o implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion or vasectomized partner) and for at least 180 days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (higher than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).