Clinical trial · Interventional
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
NCT01855854CI-TRIAL-00039331completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib
- description
- Icotinib: 250 mg is administered orally three times per day, until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
- Objective response rates
- timeFrame
- 2 months
- 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.
Secondary outcomes (2)
- measure
- Progression Free Survival
- timeFrame
- 5 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHuang 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