Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma

Inclusion Criteria:

• Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.
• The sample size estimate: 20 cases per arm.
• Males or females aged ≥18 years, < 75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
• Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
• Adequate bone marrow, renal, and liver function are required.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Allergy to anti-EGFR antibody.
• Female subjects should not be pregnant or breast-feeding.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin < 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.