A Phase I Study of Irreversible Electroporation in Patients with Inoperable Hilar Bile Duct Cancer (Klatskin Tumor)

Full Title

Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase I

Purpose

Inoperable bile duct cancer (hilar cholangiocarcinoma or Klatskin tumor) can be challenging to treat successfully. In this study, researchers are evaluating the safety and effectiveness of a procedure called irreversible electroporation (IRE or NanoKnife) in patients with hilar bile duct cancer that cannot be removed with conventional surgery.

IRE uses an electrical current that runs between two or more probes (small devices that “catch” or “receive” the current). The probes are placed on either side of a tumor, and the electrical current running between the probes destroys the cancer cells in the current’s path.

Many patients with bile duct cancer have problems with blocked bile ducts and infections caused by the blockages. Researchers believe using IRE in these patients will improve bile drainage so they have fewer problems with infection and can be treated with chemotherapy for a longer period of time. The IRE technique is approved by the U.S. Food and Drug Administration to treat other soft tissue cancers; its use in this study is considered investigational.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable hilar bile duct cancer that has not spread (metastasized) to other organs.
  • Patients with pacemakers or other implanted heart stimulating devices may not participate. Patients with epilepsy are also not eligible.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. T. Peter Kingham at 212-639-5260.

Protocol

18-489

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators