Recruitment

Recruitment Status
Completed
Estimated Enrollment
50

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;
Age 18-75 years old with performance status of 0 to 2
...
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;
Age 18-75 years old with performance status of 0 to 2
Have progressed after one chemotherapy regimen;
Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;

Exclusion Criteria

Known severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
...
Known severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Prior targeted therapy with erlotinib, gefitinib, and so on

Summary

Conditions
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

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 an...

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.

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;
Age 18-75 years old with performance status of 0 to 2
...
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;
Age 18-75 years old with performance status of 0 to 2
Have progressed after one chemotherapy regimen;
Overexpression of EGFR defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation;

Exclusion Criteria

Known severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
...
Known severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Prior targeted therapy with erlotinib, gefitinib, and so on

Locations

Beijing, Beijing, 100021
Beijing, Beijing, 100021

Tracking Information

NCT #
NCT01855854
Collaborators
Not Provided
Investigators
  • Study Chair: Yan Sun, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences Principal Investigator: Jing Huang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Study Chair: Yan Sun, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences Jing Huang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences