About this trial
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
Eligibility criteria
Qualifiers
Age: 18 to 70.
Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC].
ECOG performance score: 0 to 1.
Disqualifiers
Primary lesions or lymph node have been operated (except of operation for biopsy).
Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy.
Other malignant tumor.
Participation in other interventional clinical trials within 1 month.
Trial design
Treatments tested in this trial
- Nimotuzumab
- Gemcitabine
- Cisplatin
- Intensity-modulated radiotherapy
Treatment groups
Sponsors and collaborators
Fourth Affiliated Hospital of Guangxi Medical University
Lead sponsor
People's Hospital of Baise
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Guilin Medical University, China
Collaborator
LiuZhou People's Hospital
Collaborator
The First People's Hospital of Qinzhou
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Youjiang Medical College for Nationalities
Collaborator