Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy

Study Overview
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Brief Summary
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Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.

Detailed Description
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Currently,there is no standard second-line therapy for esophageal squamous cell carcinoma.More effective therapy for patients with this disease who developed disease progression after first line therapy is needed.Although Erlotinib is recommended in NCCN Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy,and analyse the value of biomarkers of these patient to identify who benefit.

Official Title
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PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Icotinib Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have provided a signed Informed Consent Form Age: 18-75 years old Histologically confirmed diagnosis of esophageal squamous cell carcinoma Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or taxane based palliative chemotherapy Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria Life expectancy ≥ 3 months Karnofsky score ≥70 Patient has adequate bone marrow and organ function Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelets ≥ 75 x 109/L Hemoglobin ≥ 9.0 g/dL Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 2 x ULN Creatinine ≤ 1.5 times ULN No malabsorption or other gastrointestinal disorders affecting drug absorption. No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃. Expect good compliance Exclusion Criteria: Patient has received previous treatment with EGFR inhibitors Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing Known severe hypersensitivity to Icotinib or any of the excipients of this product CNS metastases without radiotherapy and/or surgery Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks Evidence of clinically active Interstitial Lung Diseases Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ psychiatric illness that would prevent the patient from giving informed consent Patient is concurrently using other approved or investigational antineoplastic agent Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib Hydrochloride<br>Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days. | Drug: Icotinib Hydrochloride<br>* Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.<br>* Other names: Conmana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | Disease control rate of tumor | for up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | From time of diagnosis to death or lost to follow-up | Time from day 1 to date of death | 
| Time to progression | From time of diagnosis to disease progression | Time from day 1 to date of documented disease progression | 
| Adverse event | Safety data will be assessed at each study visit using NCI CTCAE version 3.0 | Each follow up vist, assessed up to 12 months | 
| EORTC QLQ-C30 and QLQ-OES18 | Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18 | Time from day 1 to date of death |