This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.
Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
Subjects with additional sites of metastasis, except known brain metastasis, are eligible.
Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled.
Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult.
Patients with known brain metastasis.
Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker.
Patient with cardiac or abdominal pacemakers or stimulators.
Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction.
Mayo Clinic
Lead sponsor
NovoCure Ltd.
Collaborator