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Clinical Trial 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.


Clinical Trial Description

Major Objective 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.

Secondary objective

1) If Fluorouracil implants application in clinical surgery could lead to the incidence of complications increased in biliary-enteric anastomosis.

2)Assess drug safety according to drug-related clinical and / or laboratory adverse events.

3)Observe the postoperative complication rate of Fluorouracil implants. 4)Observe the quality of life of patients used Fluorouracil implants. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01317069
Study type Interventional
Source Simcere Pharmaceutical Co., Ltd
Contact Yongjie Zhang, MD
Phone 86-021-81875271
Status Recruiting
Phase Phase 2
Start date June 2010
Completion date April 2013

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