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

• Status: Completed
• Trial end date: 2016-01-07
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

Inclusion Criteria:

• Patients with a histologic or cytologic diagnosis of carcinoma of the gastroesophageal junction or esophagus;

• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria;

• Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;

• Have progressed after one chemotherapy regimen;

• Age 18-75 years old with performance status of 0 to 2

Exclusion Criteria:

• Prior targeted therapy with erlotinib, gefitinib, and so on

• Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).

• Known severe hypersensitivity to icotinib or any of the excipients of this product.

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.