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The purpose of this single arm,phase â…¡ 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel and Cisplatin and Nimotuzumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel and Cisplatin and Nimotuzumab | Drug | 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) ; |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1 | up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate | the proportion of patients achieved CR, PR, or stable disease [SD] | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, | Guangzhou | 51000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40325445 | Derived | Zou Q, Cao Y, Lai Y, Fang Y, Zhang Y, Liu P, Lu L, Wu H, Huang T, Su N, Li Z, Wang X, Tian X, Li L, Liu Y, Cai Q, Xia Y. Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial. BMC Med. 2025 May 6;23(1):264. doi: 10.1186/s12916-025-04103-0. |
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| 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 | 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 | 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 | up to 18 weeks |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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