Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma

PHASE2UnknownINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

October 31, 2015

Study Completion Date

January 31, 2016

Conditions
Squamous Cell Carcinoma
Interventions
DRUG

Nimotuzumab

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)

DRUG

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)

DRUG

cisplatin

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).

RADIATION

Radiotherapy

"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)"

Trial Locations (17)

200000

Fudan University Shanghai Cancer Center, Shanghai

201100

Shanghai Chest Hospital, Shanghai

Shanghai First People's Hospital, Shanghai

210000

Cancer Hospital of Jiangsu Province, Nanjing

215006

The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital, Suzhou

225001

Northern Jiangsu People's Hospital, Yangzhou

266000

Chinese Academy of Medical Sciences Cancer Hospital, Beijing

Affiliated Hospital of Qingdao University Medical College, Qingdao

300000

Tianjin Cancer Hospital, Tianjin

310000

Zhejiang Cancer Hospital, Hangzhou

310003

The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

350000

Fujian Provincial Tumor Hospital, Fuzhou

430000

Huazhong University of Science and Technology, Union Hospital, Tongji Medical College, Wuhan

450052

First Affiliated Hospital of Zhengzhou University, Zhengzhou

510000

Cancer Center of Sun Yat-sen, Guangzhou

710000

Fourth Military Medical University Xijing Hospital, Xian

Unknown

The first bethune hospital of Jilin university, Changchun

All Listed Sponsors
lead

Biotech Pharmaceutical Co., Ltd.

OTHER