Cholangiocarcinoma Clinical Trial
Official title:
Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
Therasphere is a form of treatment that has been designed to selectively deliver radiation
to the cancer within the patient's liver. This form of treatment has been used in a number
of clinical trials and has been approved for use in the treatment of liver cancer.
The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with
TheraSphere (radioactive beads that are injected directly into the blood vessel supplying
the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic
cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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