A Phase II, Prospective Study for Icotinib in Esophageal Carcinoma Patients With EGFR Mutation as Second-line Treatment
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 mutation, the primary endpoint is
objective response rates.Secondary endpoints include progress-free survival, overall
survival, safety and so on.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rates
Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
Yan Sun, MD
Cancer Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration