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Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Sponsor: Fourth Affiliated Hospital of Guangxi Medical University
Summary
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.
Official title: Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2022-12-01
Completion Date
2027-11-30
Last Updated
2023-02-08
Healthy Volunteers
No
Interventions
Nimotuzumab
Drug: 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
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
Cisplatin
Cisplatin 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
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Locations (9)
People's Hospital of Baise
Baise City, Guangxi, China
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, China
Guilin Medical University, China
Guilin, Guangxi, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, China
the Fourth Affiliated Hospital of Guangxi Medical University
Liuchow, Guangxi, China
Second Affiliated Hospital of Guangzhou Medical University
Nanjing, Guangxi, China
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Liuzhou People's Hospital
Liuchow, Other (Non U.s.), China