Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT01232374
- Lead Sponsor
- Biotech Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nimotuzumab plus chemo-irradiation Radiotherapy Nimotuzumab，chemotherapy(cisplatin )，radiotherapy Placebo plus chemo-irradiation Placebo Placebo，chemotherapy(cisplatin)，radiotherapy Placebo plus chemo-irradiation Radiotherapy Placebo，chemotherapy(cisplatin)，radiotherapy Nimotuzumab plus chemo-irradiation cisplatin Nimotuzumab，chemotherapy(cisplatin )，radiotherapy Nimotuzumab plus chemo-irradiation Nimotuzumab Nimotuzumab，chemotherapy(cisplatin )，radiotherapy Placebo plus chemo-irradiation cisplatin Placebo，chemotherapy(cisplatin)，radiotherapy
- Primary Outcome Measures
Name Time Method 1-yr overall survivals 1 year 3-yr overall survival 3 years Response rate of Nimotuzumab combined with chemo-irradiation 2 months after radiotherapy 2-yr overall survival 2 year
- Secondary Outcome Measures
Name Time Method Distant metastasis rate 3 years Number and grade of Participants with Adverse Events 6 months Local progression-free survival 3 years Disease progression-free survival 3 years Quality of life 3 years
Trial Locations
- Locations (17)
Cancer Center of Sun Yat-sen
🇨🇳Guangzhou, Guangdong, China
Fujian Provincial Tumor Hospital
🇨🇳Fuzhou, Fujian, China
Chinese Academy of Medical Sciences Cancer Hospital
🇨🇳Beijing, Beijing, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
🇨🇳Suzhou, Jiangsu, China
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
The first bethune hospital of Jilin university
🇨🇳Changchun, Jilin, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Fourth Military Medical University Xijing Hospital
🇨🇳Xian, Shanxi, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital of Jiangsu Province
🇨🇳Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Affiliated Hospital of Qingdao University Medical College
🇨🇳Qingdao, Shandong, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
🇨🇳Wuhan, Hubei, China