Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
Detailed 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.
Interventions
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
Sponsors
Yuhong Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | for up to 6 months | Disease control rate of tumor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Time from day 1 to date of death | From time of diagnosis to death or lost to follow-up |
| Time to progression | Time from day 1 to date of documented disease progression | From time of diagnosis to disease progression |
| Adverse event | Each follow up vist, assessed up to 12 months | Safety data will be assessed at each study visit using NCI CTCAE version 3.0 |
| EORTC QLQ-C30 and QLQ-OES18 | Time from day 1 to date of death | Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18 |
Countries
China
Outcome results
None listed