NCT02611700

Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma

An Prospective, Multicenter, Double-blind, Randomized, Controlled Clinical Study of Nimotuzumab Combined With Paclitaxel and Cisplatin as First-line Treatment of Metastatic Esophageal Squamous Cell Carcinomas

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.

Detailed description

This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with TP compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.The main endpoint is OS.

Conditions

• Esophageal Squamous Cell Carcinomas

Interventions

Type	Name	Description
DRUG	Nimotuzumab	400mg,day1,weekly,until disease progression or toxicity
DRUG	Paclitaxel	175mg/m\^2,for 3 hour(Peripherally Inserted Central Catheter,PICC),day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.
DRUG	Cisplatin	60mg/m\^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
DRUG	Placebo	400mg,day1,weekly,until disease progression or toxicity

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2015-11-23
• Last updated: 2016-02-01

Locations

27 sites across 1 country: China