Study on Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump for Cholangiocarcinoma That Cannot Be Removed by Surgery

Inclusion Criteria

• Age 18 years or older.
• Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Confirmed diagnosis of intrahepatic cholangiocarcinoma (IHC), a type of liver cancer.
• Cancer that has spread only to the liver, with possible involvement of nearby lymph nodes that can be surgically removed.
• Cancer that can be measured by imaging scans, with a minimum size of 2 cm.
• Cancer that cannot be surgically removed at the time of evaluation.
• Suitable for general anesthesia and surgery to place a hepatic artery pump.
• Patients with chronic hepatitis or cirrhosis can participate if they are Child-Pugh class A.
• Adequate blood cell counts and organ function, including:
  • White blood cell count of at least 2,000/mcL.
  • Neutrophil count of at least 1,000/mcL.
  • Platelet count of at least 75,000/mcL.
  • Creatinine level of 1.8 mg/dL or lower.
  • Total bilirubin level below 1.5 mg/dL.
  • Hemoglobin level above 7 g/dL.

Exclusion Criteria

• Cancer that has spread to distant parts of the body.
• Previous treatment with chemotherapy for IHC.
• Previous treatment with floxuridine (FUDR).
• Previous radiation therapy to the liver.
• Previous liver ablative therapy.
• Diagnosis of sclerosing cholangitis, a liver disease.
• Signs of portal hypertension, such as fluid buildup in the abdomen or enlarged veins in the esophagus.
• Active infection within one week before pump placement.
• Pregnant or breastfeeding women.
• History of another cancer within the past 3 years, unless it was early stage and treated successfully.
• Life expectancy of less than 12 weeks.
• Inability to follow study procedures.
• History of nerve damage (peripheral neuropathy).