Through clinical practice, to explore if the application of Fluorouracil implant could
effectively delay the local tumor recurrence and improvement the postoperative survival time
in patients with gallbladder cancer and bile duct cancer.
Drug: Fluorouracil implant
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Locations near you
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Full eligibility criteria for NCT01317069
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01317069
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China, 200000
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View full eligibility
Tris trial is registered with FDA with number: NCT01317069. The sponsor of the trial is Simcere Pharmaceutical Co., Ltd and it is looking for 100 volunteers for the current phase.
Official trial title: A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
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