HAI Chemotherapy for Bile Duct Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Systemic chemotherapy gives chemotherapy through a vein \[intravenously (IV)\] and treats the whole body. This type of treatment has been done before and had shown that people with both pump and systemic chemotherapy had improved results. The investigators hope that this combination of treatments improves the response to chemotherapy and reduces the spread of the disease.Another purpose of this study is to learn the clinical importance of a specific type of MRI scan. The investigators would like to see if this type of MRI will help predict the response to the treatment and see if they could help the physician with their treatment plan. These scans will be done at specific time points.The last purpose of this study is to learn more about how the tumor interacts with the chemotherapy. This will be done through a biopsy taken during surgery and blood draws at specific time points.Permission from patients entering the study will be obtained to take normal and tumor liver biopsies at the time of surgery. These samples are voluntary and optional.
Research Team
William Jarnagin, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for adults over 21 with a specific liver cancer (intrahepatic cholangiocarcinoma) that can't be removed by surgery. They should have less than 70% liver involvement, good physical function, and acceptable blood counts. People with chronic hepatitis or cirrhosis can join if it's mild. Prior chemotherapy and certain local treatments are okay, but no prior FUDR treatment or radiation to the liver.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Placement
Surgical placement of the hepatic arterial infusion pump
Treatment
Participants receive HAI FUDR/Dex and systemic chemotherapy with Gemcitabine and Oxaliplatin
Imaging and Monitoring
MRI and CT scans to monitor treatment response and tumor interaction
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexamethasone
- Floxuridine (FUDR)
- Gemcitabine
- Hepatic Arterial Infusion (HAI)
- Oxaliplatin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor