The role of sonoporation-enhanced treatment in patients with inoperable pancreatic cancer

Prior treatment

• Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).

Other illness

• Operable pancreatic cancer
• Patients that are allergic to any other component of Sonazoid.
• Patient is allergic to or intolerant of any IMPs included in the chemotherapy regimen that the patient is scheduled for (Gemcitabine/Nab-Paclitaxel or FOLFIRINOX).
• Patient has severe chronic obstructive pulmonary disease,or pulmonary hypertension or unstable cardiopulmonary conditions.
• Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
• Patient has a known history of HIV infection or active Hepatitis B or Hepatitis C infection.
• Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of Sonazoid).

Lab values

• Patient requires dialysis or has severely impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 30 at the Screening Visit.
• Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the ULN) or Child Pugh Score C, at the Screening Visit

Other

• Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.
• Any reason why, in the opinion of the investigator, the patient should not participate.
• Patient is pregnant or is breast-feeding.
• Patients who are medically unstable

• A new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma
• Must be ambulatory with an ECOG performance status between 0 and 2
• Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use) an effective or highly effective birth control method
• Male patients with a female partner who is considered of childbearing potential, must agree to use a condom throughout the study and for 6 months after last exposure to the IMPs.
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
• Patient must be ≥18 years old.