NCT02611700Unknown3 期
An Prospective, Multicenter, Double-blind, Randomized, Controlled Clinical Study of Nimotuzumab Combined With Paclitaxel and Cisplatin as First-line Treatment of Metastatic Esophageal Squamous Cell Carcinomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 504
- 试验地点
- 27
- 主要终点
- Median time of overall survival(OS)
研究概览
简要总结
This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.
详细描述
This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with TP compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.The main endpoint is OS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary and sign a consent form;
- •Age≥18 years;
- •Histological diagnosis as metastatic esophageal squamous cell carcinoma, including: (1)Naked metastatic esophageal cancer：have no opportunity to receive any radical surgery or radical radiation therapy (2) recurrent metastatic esophageal cancer：recurrence after surgery or adjuvant radiotherapy or radical concurrent radio or radiochemotherapy,haven't received systemic chemotherapy and have measurable lesions outside radiotherapy target zone(3) recurrent metastatic esophageal cancer,more than 6 months after neoadjuvant or adjuvant chemotherapy;
- •When patients need to receive palliative radiotherapy,the palliative radiotherapy should complete over 4 weeks and target lesions should outside the radiotherapy target zone(radiotherapy lesions include but not limited to primary tumors, bone, lymph nodes);
- •According to RECIST 1.1 criteria, at least one measurable lesion exist;
- •Expected survival time is over 3 months;
- •Eastern Cooperative Oncology Group（ECOG）0 or 1;
- •Normal bone marrow and hematopoietic function;total bilirubin acuities≤1.5×Upper Limit Of Normal（ULN）, creatinine≤1.0×ULN, aspartate aminotransferase（AST）/alanine aminotransferase（ALT）≤2.5×ULN, ALP≤5.0×ULN, creatinine clearance > 60 ml/min, liver metastases patients: AST/ALT≤5.0×ULN;
- •Take effective contraceptive measures when in growth period;
- •Compliance is good.
排除标准
- •Have received any palliative chemotherapy for metastatic esophageal cancer
- •Recurrence or metastasis after neoadjuvant chemotherapy or postoperative adjuvant < 6 months;
- •Received any kinds of radiotherapy within 4 weeks;
- •Patients who can received palliative radiotherapy and all lesions are in one radiation zone;
- •Had received adjuvant/neoadjuvant therapy and have used paclitaxel within 6 months;
- •Had received adjuvant/neoadjuvant therapy and the cumulative dose of cisplatin was over 300 mg/m2;
- •Alone or combined with brain metastasis;
- •No measurable tumor lesions;
- •Combined with other primary malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Allergy to the component of investigational drugs;
- •Patients who are receiving the treatment of chronic or multiple doses of corticosteroids (inhaled steroids or short-term oral cortisol according to the clinical indications were allowed);
- •Haven't recovered to degree 1 from the toxicity of treatment before.
- •Concomitant with severe cardiovascular diseases, such as uncontrol heart failure, coronary heart disease, cardiomyopathy, arrhythmia,high blood pressure or history of myocardial infarction within 5 years;
- •Concomitant with serious complications, such as the activity of the digestive tract hemorrhage, perforation, severe jaundice, gastrointestinal obstruction, active clinical infection (> 2 levels of infection standard);
- •With chronic diarrhea disease and renal insufficiency;
- •Have disease affecting cognition or mental abnormal;
- •Have other severe acute or chronic diseases;
- •Pregnancy or lactation women;
- •Have participated in other clinical trials within 30 days.
研究组 & 干预措施
experimental group
Experimental
Nimotuzumab+TP(paclitaxel+cisplatin)
干预措施: Nimotuzumab (Drug)
experimental group
Experimental
Nimotuzumab+TP(paclitaxel+cisplatin)
干预措施: Paclitaxel (Drug)
experimental group
Experimental
Nimotuzumab+TP(paclitaxel+cisplatin)
干预措施: Cisplatin (Drug)
control group
Placebo Comparator
Placebo + TP(paclitaxel+cisplatin)
干预措施: Paclitaxel (Drug)
control group
Placebo Comparator
Placebo + TP(paclitaxel+cisplatin)
干预措施: Cisplatin (Drug)
control group
Placebo Comparator
Placebo + TP(paclitaxel+cisplatin)
干预措施: Placebo (Drug)
结局指标
主要结局
Median time of overall survival(OS)
时间窗: Up to 12 months
Record all the survival status of each patient and calculate the median OS of all the patients
次要结局
- Objective response rate（ORR）(Up to 12 months)
- Quality of life(baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks))
- Median time of progression-free survival（PFS）(Up to 12 months)
- Incidence of adverse events(Up to 30 days after last administration of nimotuzumab)
研究者
研究点 (27)
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