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

NCT01855854 | Completed Phase 2 DMC

• 1 other identifier: CH-GI-036
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression Free Survival

  5 months

• Overall survival

  9 months

Study Arms (1)

Icotinib

EXPERIMENTAL

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

Drug: Icotinib

Interventions

Icotinib DRUG

Icotinib: 250 mg is administered orally three times per day, until disease progression or untolerable toxicity.

Also known as: Conmana, BPI-2009

Icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• 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.

  PMID: 26980473 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

icotinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yan Sun, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Jing Huang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: January 7, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

CN (1)