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

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Collaborator: Eastern Hepatobiliary Surgery Hospital
• Treatments: Fluorouracil

Criteria

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.