Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The rate of grade 3/4 toxicity
研究概览
简要总结
Nimotuzumab 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 adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
详细描述
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. Irinotecan will be administered once every 14 days, the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels: 200mg/w, 400mg/w, 600mg/w, weekly. The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks, when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed before performing any of the study's specific procedures.
- •ECOG performance status 0-
- •Age > 18，both genders.
- •Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
- •Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
- •At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
- •Life expectancy more than 3 months.
- •K-ras is wild type
- •Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
- •Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
- •Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
- •TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis），AST and ALT≤ 2.5 x ULN or ≤ 5ULN（Liver metastasis）,Creatinine ≤ 1.5 x ULN
- •No brain metastasis
排除标准
- •Previous radiotherapy at lesions within three months
- •Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
- •Received other anti EGFR monoclonal antibody treatment
- •Complete or incomplete intestinal obstruction
- •Participation in other interventional clinical trials within 1 month
- •Psychiatric disease affected cognitive ability, including brain metastasis
- •Peripheral neuropathy lesion is more than I stage.
- •History of serious allergic or allergy
- •Pregnant or breast-feeding women
- •Patients with the history of Serious lung or hear disease
- •Other malignant tumor
研究组 & 干预措施
Nimotuzumab and Irinotecan
Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
干预措施: Nimotuzumab (Drug)
Nimotuzumab and Irinotecan
Nimotuzumab： 200, 400, 600 or 800mg weekly until progression or AEs Irinotecan：180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles
干预措施: Irinotecan (Drug)
结局指标
主要结局
The rate of grade 3/4 toxicity
时间窗: 3 months
The rate of grade 3/4 toxicity, defined as the proportion or frequency of patients who experience toxicity reactions that are classified as grade 3 or grade 4 according to CTCAE v5.0.
次要结局
- Maximum Tolerated Dose (MTD)(3 months)
- The complete response rate(3 months)
- The partial response rate(3 months)
- The disease control rate(3 months)