Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
- Conditions
- Nasopharyngeal Cancer
- Interventions
- Drug: placebo plus chemoradiotherapy
- Registration Number
- NCT01074021
- Lead Sponsor
- Biotech Pharmaceutical Co., Ltd.
- Brief Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.
- Detailed Description
Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 480
- Joined the study voluntary and signed informed consent form
- Age 18-70，both genders.
- Nasopharyngeal cancer was confirmed by pathology.
- Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
- Primary lesions can measurable.
- Karnofsky Performance Scale >70.
- Life expectancy of more than 6 months.
- Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
- Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L
- Hepatic function:ALAT、ASAT< 1.5 x ULN, TBIL< 1.5 x ULN
- Renal function: Creatinine < 1.5 x ULN
- Evidence of distant metastasis
- Primary lesions or lymph node have been operated (except of operation for biopsy)
- Previous radiotherapy
- Received other anti EGFR monoclonal antibody treatment
- Previous chemotherapy or immunization therapy
- Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
- Participation in other interventional clinical trials within 1 month
- Peripheral neuropathy is more than I stage
- Pregnant or breast-feeding women and women who refused to take contraceptive method
- History of serious allergic or allergy
- History of Serious lung or heart disease
- Refused or can't signed informed consent form
- Drug abuse or alcohol addiction
- Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo plus chemoradiotherapy placebo plus chemoradiotherapy - Nimotuzumab plus chemoradiotherapy Nimotuzumab -
- Primary Outcome Measures
Name Time Method To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation 3 months after the Nimotuzumab treatment finished To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation within study period
- Secondary Outcome Measures
Name Time Method To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment 3 years To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3 3 year
Trial Locations
- Locations (24)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China
The Affiliated Renji Hosptial of ShanghaiJiao Tong University
🇨🇳Shanghai, China
Xiamen First Hospital
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Affiliated Cancer Hospital of Haerbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Liaoning Province Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Shandong Caner Hospital
🇨🇳Jinan, Shandong, China
Sichuan Province Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The General Hospital of the People's Liberation Army
🇨🇳Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳ShangHai, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Affiliated Tumor Hospital of Guangxi Medical University
🇨🇳Xining, Guangxi, China
The Affiliated Cancer Hospital of Guangzhou Medical Hospital
🇨🇳Guangzhou, Guangdong, China
The Fourth Hebei Province Hospital
🇨🇳Shijiazhuang, Hebei, China
Hubei Province Caner Hospital
🇨🇳Wuhan, Hubei, China
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
🇨🇳Beijing, China
West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)
🇨🇳Chengdu, Sichuan, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China