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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Intravenous nimotuzumab (200 mg on days 1, 8, and 15) ; Intravenous docetaxel (75 mg/m2 on day 1) ; Intravenous cisplatin (75 mg/m2 on day 1) ;
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Guangzhou, China
overall response rate
the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1
Time frame: up to 18 weeks
disease control rate
the proportion of patients achieved CR, PR, or stable disease \[SD\]
Time frame: up to 18 weeks
duration of response
time interval from the first day of documented response to progressive disease \[PD\] or death from any cause
Time frame: From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months
progression-free survival
time interval from the enrolled date to the documented PD or death from any cause or censored at the last follow-up
Time frame: From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months
overall survival
time interval from the enrolled date to death from any cause or last follow-up
Time frame: From date of the enrollment until the date of the documented death, assessed up to 72 months
adverse events
treatment-related adverse events graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: up to 18 weeks
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