NCT02749526

Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.

Detailed description

1. Research purpose: Endostar (recombinant human endostatin) continuous intravenous infusion combined with chemotherapy for stage Ⅲ resectable or potentially resectable esophageal cancer efficacy and safety and to maintain the efficacy and safety. 2. The main objectives: R0 resection rate Secondary objectives: 1. pCR rate 2. 3-year disease-free survival 3. Security and complications 4. DFS, OS 5. Quality of Life 3.The number of research centers and research time: This study intends to preside and implemented by the Jiangsu Provincial People's Hospital, Professor Gu Yanhong. The trial is scheduled to start in September 2015, planned to stop in June 2016 into the group, one patient surgery follow-up to the last end, get the primary endpoint and safety, surgical complications secondary endpoint. This study will continue to follow-up the patient DFS, OS and other secondary end points.

Conditions

• Esophageal

Interventions

Type	Name	Description
DRUG	"Endostar"	30mg civ24h d0-6.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
DRUG	Liposo	135mg/m2 D1.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
DRUG	cisplatin	25mg/m2 D1-3.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
DRUG	Gimeracil and Oteracil Potassium （Tegafur）	40mg bid，D1-14.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-04-25
• Last updated: 2022-07-29

Locations

1 site across 1 country: China