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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.
Full description
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.
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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
Patient has adequate liver function
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
Primary purpose
Allocation
Interventional model
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50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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