Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
Conditions
Local Advanced Esophageal Squamous Cell Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
Nimotuzumab, local advanced esophageal squamous cell carcinoma, chemo-irradiation
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Placebo, Radiotherapy and Chemotherapy Type: Drug
Name: Nimotuzumab, Radiotherapy and Chemotherapy Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Joined the study voluntarily and signed informed consent form;

- Age 18-75

- Both genders

- Esophageal squamous cell carcinoma confirmed by pathology

- Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)

- No radiotherapy, chemotherapy or other treatments prior to enrollment

- PS ECOG 0-2

- Life expectancy of more than 3 months

- Target lesions measurable

- Hemoglobin(Hb)≥9 g/dL

- WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L

- platelet count (Pt) ≥100x 109/L

- Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN

- Renal function: creatinine < 1.5 x ULN

- No immuno-deficiency

- Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

- Complete esophageal obstruction

- Deep esophageal ulcer

- Esophageal perforation

- Haematemesis

- After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy

- Esophageal stent or tracheal stent placed

- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years

- Participation in other interventional clinical trials within 30 days

- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives

- Drug addiction

- Alcoholism or AIDS

- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior

- History of serious allergic or allergy

- Patients who are not suitable to participate in the trial according to researchers.
Locations
Beijing Cancer Hospital
Beijing, Beijing, China
Status: Not yet recruiting
Contact: Guangying Zhu - zgypu@yahoo.com.cn
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing, China
Status: Not yet recruiting
Contact: Lvhua Wang - wlhwq@yahoo.com
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China
Status: Not yet recruiting
Contact: Jianji Pan - panjianji@126.com
Cancer Center of Sun Yat-sen
Guangzhou, Guangdong, China
Status: Not yet recruiting
Contact: Mengzhong Liu - 13802547520 - lmz1955@163.com
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Status: Not yet recruiting
Contact: Qingxia Fan - fqx2243@yahoo.com.cn
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
Wuhan, Hubei, China
Status: Not yet recruiting
Contact: Gang Wu - wugangzr@yahoo.com.cn
Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Status: Not yet recruiting
Contact: Ye Tian - dryetian@hotmail.com
Second Affiliated Hospital of China Medical University (Shengjing Hospital)
Shenyang, Liaoning, China
Status: Not yet recruiting
Contact: Rong Wu - wur@sj-hospital.org
Cancer Hospital of Jiangsu Province
Nanjing, Nanjing, China
Status: Not yet recruiting
Contact: Jifeng Feng - fjif@vip.sina.com
Affiliated Hospital of Qingdao University Medical College
Qingdao, Shandong, China
Status: Not yet recruiting
Contact: Jun Liang - 1396898909
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
Status: Recruiting
Contact: Guo Liang Jiang, MD, FACR (Hon.), Professor - 8621-64439052 - jianggl47@hotmail.com
Shanghai Chest Hospital
Shanghai, Shanghai, China
Status: Not yet recruiting
Contact: Changxing Lv
Shanghai First People's Hospital
Shanghai, Shanghai, China
Status: Not yet recruiting
Contact: Guoqi Zhao - zhaogq7i7@yahoo.com.cn
Shanghai Jiaotong University Renji Hospital
Shanghai, Shanghai, China
Status: Not yet recruiting
Contact: Ming Ye - renjiyeming@gmail.com
Fourth Military Medical University Xijing Hospital
Xian, Shanxi, China
Status: Not yet recruiting
Contact: Mei Shi - Rtdxjh@fmmu.edu.cn
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Status: Not yet recruiting
Contact: You Lu - 13981935716 - radyoulu@hotmail.com
Tianjin Cancer Hospital
Tianjin, Tianjin, China
Status: Not yet recruiting
Contact: Ping Wang - 23519953
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Not yet recruiting
Contact: Shenglin Ma
Start Date
August 2010
Completion Date
February 2014
Sponsors
Biotech Pharmaceutical Co., Ltd.
Source
Biotech Pharmaceutical Co., Ltd.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page