A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer

This is an interventional treatment trial for Gallbladder Cancer Read More

Inclusion Criteria:

• The patients with gallbladder and bile duct cancer diagnosis by surgical exploration, or intraoperative frozen biopsy (Annex 2).
• Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 3 months.
• Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:

Blood: WBC count > 3.0 × 109 / L, Platelet count> 100 × 109 / L, Hb > 8.0g/dl. Liver function：serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 3 times the upper limit of normal.

Renal function: creatinine less than 1.5 times the upper limit of normal.

• Participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test.
• Patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past.
• Patients who can understand the circumstances of this study and signed informed consent.

Exclusion Criteria:

• Currently is receiving effective treatment；
• Pregnancy, breast-feeding patients；
• Primary brain tumors or central nervous system metastatic tumor is not controlled;
• Patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment.
• Patients with purulent and chronic infected wounds which delayed healing.
• Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
• Patients has a history of mental illness and difficult to control;
• Patients who was considered inappropriate to participate in the trials by the researchers.