A Phase 2 interventional study of Docetaxel and Cisplatin and Nimotuzumab in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 48 is close to the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity.
Drug: Docetaxel and Cisplatin and Nimotuzumab
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) ;
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
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University