NCT01393080Unknown不适用
The Study of Nimotuzumab in Combination With Paclitaxel Liposome and Carboplatin (TP Regimen) for Patient With the Advanced Non-small Cell Lung Cancer( NSCLC)
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Nimotuzumab (hR3) 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 efficacy has been shown in adults with head and neck cancer. This study assesses the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with NSCLC. This is a randomized, muti-center sites trial of this treatment.
详细描述
This is a randomized, muti-center sites trial of Nimotuzumab combination with Paclitaxel Liposome and Carboplatin (TP regimen) treatment.
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
- 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
- •Signature of the informed consent form
- •Ages from 18 to 70 years old; both male and female.
- •Pathologically and/or cytologically ① the patients of ⅢB～Ⅳstage NSCLC; ② the patients of IIIA stage NSCLC could not receive the operation or could not operate. ③ the patients of IIIA stage NSCLC are recurrent postoperation.
- •EGFR mRNA from peripheral bloods is positive by ELISA or the expression of EGFR from tumor tissue is positive by immunohistochemical staining.
- •Functions of major organs( haemogram,heart,liver,kidney)are basically normal, White blood count ≥3.5 x 109/L with neutrophils ≥1.5 x 109/L, platelet count≥100 x 109/L, and hemoglobin ≥90g/L.
- •Total bilirubin ≤1.5 times upper limit of normal (ULN) range; alkaline phosphatase(ALP)≤ 2.5 times ULN, Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, serum creatinine ≤ 1.2 times ULN .
- •With ECOG performance status 0-2;
- •Both female and male patients must use adequate methods of contraception.
排除标准
- •Participation other clinical trials within 1 month prior to inclusion in the trial.
- •Previous targeted treatment of TKI or EGFR antibodies prior to inclusion in the trial.
- •Previous paclitaxel liposome and carboplatin (TP) chemotherapy prior to inclusion in the trial.
- •With other serious internal diseases or uncontrolled infection;refractoriness dysentery or enterospasm, intestinal obstruction.
- •Cardiovascular diseases history (1)Uncontrollable hypertension, unstable angina, heart infarction, or congestive heart failure and arrhythmia ( happened within 12 month prior to inclusion in the trial) (2)Ischemia checked by ECG, or clinical diagnostic Heart valve disease (3)The patients of Grade II(CTC AE 3.0) of arrhythmia, myocardial ischemia, troponin T abnormality, hypertension or left ventricular ejection fraction <50%，could not include in the TP+ nimotuzumab test group;
- •With drug addition, I.e. ,drug-taking, drug-taking for long time; type B hepatitis and C hepatitis in active stage, or with AIDS.
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, curative carcinoma of prostate.
- •With history of serious allergic or allergy.
- •Patients with less compliance
- •Pregnancy, lactation, fertility but using a prohibited contraceptive method.
- •Not fit for the clinical trial judged by the investigator.
研究组 & 干预措施
Nimotuzumab and TP regimen
Experimental
- TP Regimen ：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle, for 4 cycles.
- Nimotuzumab : 200mg/w, weekly, for 6 weeks; Consolidation treatment， 200mg every 2 weeks, until the end of 4 cycles of chemotherapy or the disease progression.
干预措施: Nimotuzumab and TP regimen (Drug)
TP Regimen
Placebo Comparator
TP Regimen：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle, for 4 cycles.
干预措施: TP regimen (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 12months
次要结局
- Overall survival Time(3 years)
研究者
研究点 (1)
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