Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT03708822
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2018-10-15
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Docetaxel and Cisplatin and Nimotuzumab
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.
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) ;
Interventions
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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) ;
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnant or lactating female;
* patients received other clinical trails within 3 months;
* had serious infections, comorbidities or vital organs dysfunction.
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Qingqing Cai
Chief physician
Locations
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Guangzhou, , China
Countries
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References
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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.
Other Identifiers
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B2018-097-01
Identifier Type: -
Identifier Source: org_study_id
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