A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 144
- 试验地点
- 17
- 主要终点
- 3-yr overall survival
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 phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety and the potential efficacy of Nimotuzumab. The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.
详细描述
The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to further investigate its side-effect and toxicity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Joined the study voluntarily and signed informed consent form;
- •Age 18-75
- •Both genders
- •Esophageal squamous cell carcinoma confirmed by pathology
- •Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
- •No radiotherapy, chemotherapy or other treatments prior to enrollment
- •PS ECOG 0-2
- •Life expectancy of more than 3 months
- •Target lesions measurable
- •Hemoglobin（Hb）≥9 g/dL
- •WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
- •platelet count (Pt) ≥100x 109/L
- •Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN
- •Renal function: creatinine < 1.5 x ULN
- •No immuno-deficiency
- •Use of an effective contraceptive for adults to prevent pregnancy.
排除标准
- •Complete esophageal obstruction
- •Deep esophageal ulcer
- •Esophageal perforation
- •Haematemesis
- •After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
- •Esophageal stent or tracheal stent placed
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- •Participation in other interventional clinical trials within 30 days
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- •Drug addiction
- •Alcoholism or AIDS
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- •History of serious allergic or allergy
- •Patients who are not suitable to participate in the trial according to researchers.
研究组 & 干预措施
Nimotuzumab plus chemo-irradiation
Nimotuzumab，chemotherapy(cisplatin )，radiotherapy
干预措施: Nimotuzumab (Drug)
Nimotuzumab plus chemo-irradiation
Nimotuzumab，chemotherapy(cisplatin )，radiotherapy
干预措施: cisplatin (Drug)
Nimotuzumab plus chemo-irradiation
Nimotuzumab，chemotherapy(cisplatin )，radiotherapy
干预措施: Radiotherapy (Radiation)
Placebo plus chemo-irradiation
Placebo，chemotherapy(cisplatin)，radiotherapy
干预措施: Placebo (Drug)
Placebo plus chemo-irradiation
Placebo，chemotherapy(cisplatin)，radiotherapy
干预措施: cisplatin (Drug)
Placebo plus chemo-irradiation
Placebo，chemotherapy(cisplatin)，radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
3-yr overall survival
时间窗: 3 years
2-yr overall survival
时间窗: 2 year
Response rate of Nimotuzumab combined with chemo-irradiation
时间窗: 2 months after radiotherapy
1-yr overall survivals
时间窗: 1 year
次要结局
- Distant metastasis rate(3 years)
- Number and grade of Participants with Adverse Events(6 months)
- Local progression-free survival(3 years)
- Disease progression-free survival(3 years)
- Quality of life(3 years)