This phase II trial studies how well of irreversible electroporation (IRE) in treating patients with bile duct cancer that has spread to nearby tissue or lymph nodes, and cannot be removed by surgery. IRE uses an electrical current that runs between two or more probes and may destroy the cancer cells in the current’s path. Using IRE in patients with bile duct cancer may improve bile drainage so patients have fewer problems with infection and may be treated with chemotherapy for a longer period of time.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03769753.
PRIMARY OBJECTIVES:
I. To assess patency of biliary drainage.
SECONDARY OBJECTIVES:
I. Duration of hospital stay.
II. Complications.
III. Quality of life.
IV. Tumor response on computed tomography (CT) imaging and blood biomarker response.
V. Time between IRE and start of palliative chemotherapy.
VI. Duration of palliative chemotherapy.
VII. Progression-free and overall survival.
VIII. Success rate of completing IRE (defined as percentage of planned pulses completed).
OUTLINE:
Patients undergo IRE.
After completion of study treatment, patients are followed up at 2 and 4 weeks, and at 6, 12, and 24 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorThomas Peter Kingham
