CompletedPhase 2

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

China54 participantsStarted 2013-05

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective response rates

Timeframe: 2 months

Trial details

NCT IDNCT01855854

SponsorBetta Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Adenocarcinoma of the Gastroesophageal Junction trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.