Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH
Conditions
Adenocarcinoma of the Gastroesophageal Junction - Esophageal Carcinoma
Conditions: official terms
Adenocarcinoma - Carcinoma - Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Icotinib
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China
Status: Recruiting
Contact: Jing Huang, MD - 0086-87788103
Start Date
May 2013
Completion Date
November 2015
Sponsors
Betta Pharmaceuticals Co.,Ltd.
Source
Betta Pharmaceuticals Co.,Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page