Brief Title
Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Official Title
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
Brief Summary
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
Docetaxel and Cisplatin and Nimotuzumab
Study Arms / Comparison Groups
Docetaxel and Cisplatin and Nimotuzumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
48
Start Date
November 1, 2018
Completion Date
December 30, 2026
Primary Completion Date
December 30, 2020
Eligibility Criteria
Inclusion Criteria: - biopsy proved nasopharyngeal carcinoma; - stage IVc according to Union for International Cancer Control (UICC) edition VIII,or recurrent disease after chemotherapy and/or radiotherapy; - 18 years or older; without other malignancy; - proper functioning of the major organs. Exclusion Criteria: - allergic to docetaxel or cisplatin or Nimotuzumab ; - female within gestation period or lactation; - patients received drug of other clinical trail within 3 months
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, 0086-20-87342823, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03708822
Organization ID
B2018-097-01
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
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Verification Date
April 2019