Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH

Phase 2

Completed

• Conditions: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Carcinoma
• Interventions: Drug: Icotinib

• Registration Number: NCT01855854
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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, 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-17
• Primary Completion: 2015-08
• Study Completion: 2016-01-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	Icotinib: 250 mg is administered orally three times per day, until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective response rates	2 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	5 months	A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Overall survival	9 months	Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China