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

Overview

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.

Full Title of Study: “A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Detailed 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.

Interventions

  • Drug: Fluorouracil implant
    • Before the abdomen was closed, fluorouracil implant 1000mg was sprayed evenly on the surface of tumor resection area, and some of the drugs were put into mesenteric root based on the location

Arms, Groups and Cohorts

  • Experimental: Fluorouracil implant

Clinical Trial Outcome Measures

Primary Measures

  • duration of survival after operation
    • Time Frame: 3 years

Secondary Measures

  • disease free survival
    • Time Frame: 1 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Simcere Pharmaceutical Co., Ltd
  • Collaborator
    • Eastern Hepatobiliary Surgery Hospital
  • Provider of Information About this Clinical Study
    • Yongjie Zhang MD, Eastern Hepatobiliary Surgery Hospital
  • Overall Contact(s)
    • Yongjie Zhang, MD, 86-021-81875271

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