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

Phase 2
18 Years
70 Years
Open (Enrolling)
Gallbladder Cancer, Bile Duct Cancer

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

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

Outcome Measure:

duration of survival after operation

Outcome Time Frame:

3 years

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

April 2013

Related Keywords:

  • Gallbladder Cancer
  • Bile Duct Cancer
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms