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A Phase II, Prospective Study for Icotinib in Esophageal Carcinoma Patients With EGFR Mutation as Second-line Treatment

Phase 2
18 Years
75 Years
Open (Enrolling)
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Carcinoma

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Trial Information

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.

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;

- Positive EGFR mutation;

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rates

Outcome Description:

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.

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Yan Sun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

December 2014

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms