Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma

Inclusion Criteria:

• biopsy proved nasopharyngeal carcinoma;
• stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
• 18-70 years;
• without other malignancy;
• had at least one measurable disease;
• had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• estimated life expectancy exceeding 3 months;
• adequate functions of the major organs.

Exclusion Criteria:

• allergic to docetaxel or cisplatin or nimotuzumab;
• pregnant or lactating female;
• patients received other clinical trails within 3 months;
• had serious infections, comorbidities or vital organs dysfunction.