Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer

Prior treatment

• Unmanaged concurrent illnesses, encompassing psychiatric conditions or challenging social circumstances, that, as per the investigator's judgment, could undermine compliance to the study protocols or pose an unacceptable risk to the patient.

Other illness

• Cancer has spread to other organs or non-regional lymph nodes (Metastases).
• Unknown stage or recurrent pancreatic cancer.

Age

• Concurrent or prior malignancy unless disease-free for ≥3 years, with exceptions for nonmelanoma skin cancer, carcinoma in situ of the cervix or bladder, or Gleason Grade \< 7 organ-confined prostate cancer. This may be subject to investigator's judgement based on individual patient circumstances and the nature of the malignancy.

Other

• Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement.
• Inability to consent.
• Pancreatic tumor is different from adenocarcinoma (e.g., neuroendocrine, metastases). Adenosquamous is allowed.
• Patient contraindication to Gemcitabine treatments.
• Patients in which iodine contrast is contraindicated.
• Presence of structures that impede tumor access.
• Pregnant or nursing individuals.

• Able to comply with scheduled visits, treatment plan, able to undergo catheterization, imaging procedures, laboratory tests, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
• Voluntarily agrees to participate and has duly singed the Informed Consent Form.
• Age 18 years or older.
• Histologically confirmed, locally advanced pancreatic cancer.
• Systemic treatment with IV chemotherapy for at least six months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The target tumor is a measurable tumor according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 prior to initiating Extroducer® Gemcitabine treatment.
• Stable disease or locally progressive disease without signs of metastatic disease as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose.
• Locally Advanced Pancreatic Cancer not amenable to resection as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose.
• Have acceptable organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm³ (1.5x109 cells/L) ii. Hemoglobin ≥ 9.0 g/dL iii. Platelets ≥ 100,000/µL iv. Total bilirubin ≤ 2 × upper limit of normal (ULN). v. AST (Aspartate Aminotransferase) ≤ 3 × ULN. vi. ALT (Alanine Aminotransferase) ≤ 3 × ULN vii. Creatinine Within 1.5 x ULN OR Creatinine clearance ≥ 60 mL/min for patients with creatinine levels above 1.5 x ULN.
• Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and must agree to use a medically acceptable and highly effective contraception from enrollment until 6 months after final study treatment of Gemcitabine.
• Male subjects who are planning to father a child (i.e., planning a pregnancy with a partner) during the clinical investigation.
  • Male subjects must agree to use highly effective contraception with female partners of childbearing potential during the clinical investigation and for 3 months after the last dose of Gemcitabine and must not donate sperm during this period.
• Acceptable methods include: a condom in addition to combined hormonal contraception, progestogen-only contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion in the female partner, or vasectomy of the male participant (confirmed azoospermia).
• Sexual abstinence is acceptable only if it is the subject's usual and preferred lifestyle; periodic abstinence and withdrawal are not acceptable.