drugset / Trial / NCT02269904

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

NCT02269904 ↗

Phase 2 Unknown 120 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2014-04
Primary completion
2018-04
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator fluorouracil Small molecule 800 mg Other
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous

Indications

No indication recorded.