Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Capecitabine; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

1. primary gastric cancer, Phase III

2. D2 radical gastrectomy(R0)

3. 18 year old or above

4. KPS≥70%；

5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L

6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.

7. 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 Criteria:

1. non-initial gastric cancer；

2. having the other uncontrolled diseases.

3. obvious loss of weight ( more than 10% within 6 weeks )

4. the female in pregnancy or feeding.

5. contraindication to study drug

6. participating in other clinical trial and at the time of treatment period.