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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab plus chemo-irradiation | Experimental | Nimotuzumab,chemotherapy(cisplatin ),radiotherapy |
|
| Placebo plus chemo-irradiation | Placebo Comparator | Placebo,chemotherapy(cisplatin),radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of Nimotuzumab combined with chemo-irradiation | 2 months after radiotherapy | |
| 1-yr overall survivals | 1 year | |
| 2-yr overall survival | 2 year | |
| 3-yr overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local progression-free survival | 3 years | |
| Disease progression-free survival | 3 years | |
| Distant metastasis rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences Cancer Hospital | Beijing | Beijing Municipality | 266000 | China | ||
| Fujian Provincial Tumor Hospital |
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| Placebo | Drug | 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 | Drug | 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). |
|
| Radiotherapy | Radiation | 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) |
|
| 3 years |
| Number and grade of Participants with Adverse Events | 6 months |
| Quality of life | 3 years |
| Fuzhou |
| Fujian |
| 350000 |
| China |
| Cancer Center of Sun Yat-sen | Guangzhou | Guangdong | 510000 | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Huazhong University of Science and Technology, Union Hospital, Tongji Medical College | Wuhan | Hubei | 430000 | China |
| Cancer Hospital of Jiangsu Province | Nanjing | Jiangsu | 210000 | China |
| The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital | Suzhou | Jiangsu | 215006 | China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| The first bethune hospital of Jilin university | Changchun | Jilin | China |
| Affiliated Hospital of Qingdao University Medical College | Qingdao | Shandong | 266000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 201100 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 201100 | China |
| Fourth Military Medical University Xijing Hospital | Xian | Shanxi | 710000 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
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