Status:
COMPLETED
Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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,...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01855854
Start Date
May 1 2013
End Date
January 7 2016
Last Update
July 5 2019
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021