Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Disease control rate
Disease control rate of tumor
Time frame: for up to 6 months
Overall survival
From time of diagnosis to death or lost to follow-up
Time frame: Time from day 1 to date of death
Time to progression
From time of diagnosis to disease progression
Time frame: 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
Time frame: 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 frame: Time from day 1 to date of death
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