Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.
The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks. Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China
Cancer Center of Sun Yat-sen
Guangzhou, Guangdong, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
Wuhan, Hubei, China
Cancer Hospital of Jiangsu Province
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The first bethune hospital of Jilin university
Changchun, Jilin, China
Affiliated Hospital of Qingdao University Medical College
Qingdao, Shandong, China
...and 7 more locations
Response rate of Nimotuzumab combined with chemo-irradiation
Time frame: 2 months after radiotherapy
1-yr overall survivals
Time frame: 1 year
2-yr overall survival
Time frame: 2 year
3-yr overall survival
Time frame: 3 years
Local progression-free survival
Time frame: 3 years
Disease progression-free survival
Time frame: 3 years
Distant metastasis rate
Time frame: 3 years
Number and grade of Participants with Adverse Events
Time frame: 6 months
Quality of life
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.