Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

Inclusion Criteria:

* Histologically proven esophageal squamous cell carcinoma;
* 18 ≤ age ≤ 70;
* ECOG 0-2;
* Previously Treated with platinum or paclitaxel based regimen;
* Uni-dimensionally measurable disease (CT or MRI as per RECIST);
* Patients should have a projected life expectancy of at least 3 months;
* Completion of baseline quality of life questionnaire
* Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy with 5-FU or irinotecan after recurrence or metastasis;
* adjuvant chemotherapy with 5-FU-based chemotherapy within 6 months prior to the start of study treatment;
* Active infection requiring antibiotics
* Pregnant, lactating women
* Psychiatric illness, epileptic disorders
* Concurrent systemic illness not appropriate for chemotherapy
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma