RPCEC00000071已完成1 期
Phase Ib/IIa clinical trial: Use of h-R3 monoclonal antibody and radiotherapy to treat patients with advanced epithelial head and neck tumors.
Center of Molecular Immunology (CIM)0 个研究点目标入组 12 人开始时间: 2010年12月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •1.Patients with epithelial head and neck tumors in oral cavity and mesopharynx, stages III or IV, eligible for radiant treatment. 2.Patients with epithelial head and neck tumors not eligible for surgical treatment or undergoing relapse upon inclusion. 3.EGF-R expression confirmation by immunohistochemistry. 4.Patient’s consent in writing. 5.Age from 18 to 75 years, of both sexes. 6.WHO Performance Status lower than or equal to 2. 7.Six month life expectancy. 8.Clinical laboratory parameters: Hb >10 g/l; total leukocytes over 4 x 109 cells/l; platelets > 100 x 109/L. Liver function within normal limits and/or patients with history of liver condition confirmed by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine?132 mmol/l.
排除标准
- •1.Non compliance with inclusion criteria. 2.Patients treated with murine R3 MaB. 3.Pregnancy or breastfeeding. 4.Decompensated chronic disease: cardiopathy, diabetes, high blood pressure. 5.History of hypersensitivity to this or any similar product. 6.Fever 7.Severe septic processes. 8.Acute or serious allergic conditions.
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