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.
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.
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.
Parallel
Nimotuzumab
DrugDrug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .
Gemcitabine
DrugGemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
Cisplatin
DrugCisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
Intensity-modulated radiotherapy
RadiationDefinitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
overall survival(OS)
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.
Tumor control probability (TCP)
Tumor control probability is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Disease-free survival(DFS)
DFS is defined as the time from randomization to the first documented disease progression or death due to disease progression per RECIST 1.1. DFS will be measured by the Method of Kaplan and Meier.
Locoregional failure-free survival(LRRFS)
LRRFS is defined as the time from randomization to the date of locoregional relapse per RECIST 1.1. LRRFS will be measured by the Method of Kaplan and Meier.
Distant Metastasis-free survival(DMFS)
DMFS is defined as the time from randomization to the date of first distant metastasis. DMFS will be measured by the Method of Kaplan and Meier.
Click on the lead sponsor to view all of their trials.
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
