Status:
UNKNOWN
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
DSF
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marke...
Eligibility Criteria
Inclusion
- primary gastric cancer, Phase III
- D2 radical gastrectomy(R0)
- 18 year old or above
- KPS≥70%；
- suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
- suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
- suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .
- 9\. the authorized ICF must be signed
Exclusion
- non-initial gastric cancer；
- having the other uncontrolled diseases.
- obvious loss of weight ( more than 10% within 6 weeks )
- the female in pregnancy or feeding.
- contraindication to study drug
- participating in other clinical trial and at the time of treatment period.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02269904
Start Date
April 1 2014
End Date
June 1 2018
Last Update
October 21 2014
Active Locations (1)
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1
Heilongjiang Cancer Hospital
Harebin, Heilongjiang, China, 150000