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

A Phase II, Prospective Study for Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression or Positive FISH as Second-line Treatment

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Carcinoma; Adenocarcinoma of the Gastroesophageal Junction
• Intervention / Treatment: Drug: Icotinib

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Icotinib; Icotinib: 250 mg is administered orally three times per day, until disease progression or unacceptable toxicity.	Drug: Icotinib; Icotinib: 250 mg is administered orally three times per day, until disease progression or untolerable toxicity.; Other Names: BPI-2009; Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	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.	5 months
Overall survival	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.	9 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Study Chair: Yan Sun, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• Huang J, Fan Q, Lu P, Ying J, Ma C, Liu W, Liu Y, Tan F, Sun Y. Icotinib in Patients with Pretreated Advanced Esophageal Squamous Cell Carcinoma with EGFR Overexpression or EGFR Gene Amplification: A Single-Arm, Multicenter Phase 2 Study. J Thorac Oncol. 2016 Jun;11(6):910-7. doi: 10.1016/j.jtho.2016.02.020. Epub 2016 Mar 12.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): January 7, 2016

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (ESTIMATE): May 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: CH-GI-036