A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 24
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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
排除标准
- •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
研究组 & 干预措施
Nimotuzumab plus chemoradiotherapy
干预措施: Nimotuzumab (Drug)
placebo plus chemoradiotherapy
干预措施: placebo plus chemoradiotherapy (Drug)
结局指标
主要结局
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
时间窗: 3 months after the Nimotuzumab treatment finished
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
时间窗: within study period
次要结局
- 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)