NCT01855854

Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH

A Phase II, Prospective Study for Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression or Positive FISH as Second-line Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates.

Detailed description

Epidermal growth factor receptor (EGFR) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.EGFR is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.This study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with EGFR overexpression (IHC 3+) or positive FISH, the primary endpoint is objective response rates. Secondary endpoints include progress-free survival, overall survival, safety and so on.

Conditions

• Adenocarcinoma of the Gastroesophageal Junction
• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Icotinib	Icotinib: 250 mg is administered orally three times per day, until disease progression or untolerable toxicity.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-08-01
• Completion: 2016-01-07
• First posted: 2013-05-17
• Last updated: 2019-07-05

Locations

1 site across 1 country: China