NCT02039791Unknown2 期
Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- resection rate
研究概览
简要总结
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 phaseⅡtrial is designed to assess the resection rate and pathological complete response of nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.
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
- •Age:18-70 years
- •Histological confirmed Cervical squamous cell carcinoma
- •FIGO Stage: IB2-IIIB
- •Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken.
- •At least one lesions can be measured
- •No previous therapy
- •ECOG performance status 0-2
- •Life expectancy of more than 6 months
- •Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine<1.5mg/dl or creatinine clearance rate>60ml/min；normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN
- •Without lung or heart disease
- •Without active infection
- •Signed informed consent and submit to the organization of research
排除标准
- •Severe systemic or uncontrolled disease, unfit for chemotherapy
- •Neuropathy caused by any reason
- •Psychiatric disease
- •Other malignant tumor
- •Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level
- •Infection and severe systemic disease
- •Received other anti EGFR monoclonal antibody treatment
- •Participation in other interventional clinical trials
- •Allergic constitution or history of drug allergy
- •Pregnant or breast-feeding or refused to take contraceptive method
- •Poor compliance
研究组 & 干预措施
Nimotuzumab plus chemoradiotherapy
Experimental
干预措施: Nimotuzumab (Biological)
Nimotuzumab plus chemoradiotherapy
Experimental
干预措施: Carboplatin (Drug)
Nimotuzumab plus chemoradiotherapy
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
resection rate
时间窗: the day right after surgery
Pathological response rate
时间窗: the day right after surgery
次要结局
- objective response rate（ORR）(The first seven weeks after the end of treatment)
- Progression free survival progression-free survival (PFS)(Follow-up is for three consecutive years after surgery. Once every three months in the first year, and then once every six months in the second and third year.)
研究者
研究点 (1)
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