An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
研究概览
简要总结
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.
详细描述
The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment.
- •Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations.
- •At least one of the tumor lesions measurable.
- •Functional Status: PS (ECOG) > 0-
- •Normal Bone Marrow Function: White blood cell count > 4×109/L, hemoglobin >90g/L, and platelet count >100×109/L.
- •Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) < 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) < 1.5 x ULN and serum creatinine < 1.5 x ULN.
- •Life expectancy of more than 6 months.
- •All the patients signed the informed consent.
- •Follow up regularly and comply with test requirements.
排除标准
- •Patients with recurrent cervical lymph nodes alone.
- •Evidence of distant metastasis
- •The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy.
- •Creatinine clearance < 30ml/min
- •Has received epidermal growth factor targeting therapy.
- •Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix).
- •Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
- •Active systemic infection.
- •History of Serious lung or heart disease.
- •Drug or alcohol addiction.
- •Persons without capacity for civil conduct or persons with limited capacity for civil conduct.
- •The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study.
- •To receive chronic systemic immunotherapy or hormone therapy other than this study.
- •Women who are pregnant or breast feeding
- •Participation in other drugs clinical trials within 1 month.
研究组 & 干预措施
Nimotuzumab plus IMRT
Patients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks concurrent with IMRT.
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
时间窗: Three month after patients subject to the treatment
The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
Toxicity of this combined treatment for recurrent NPC patients
时间窗: Three month after patients subject to the treatment
Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0
次要结局
- Local Progression free survival(Three years)
- Disease-free survival(Three years)
- Overall survival(Three years)