A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- duration of survival after operation
研究概览
简要总结
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.
详细描述
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
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fluorouracil implant
干预措施: Fluorouracil implant (Drug)
结局指标
主要结局
duration of survival after operation
时间窗: 3 years
次要结局
- disease free survival(1 years)