RPCEC00000295尚未招募2 期
Phase II-III clinical trial, controlled, randomized, in parallel, adaptive design in two stages, compared, in patients with inoperable stage III epidermoid histology NSCLC, treated with concurrent CT-RT plus Nimotuzumab vs concurrent CT-RT. - Nimotuzumab in NSCLC concomitant with CRT
Center of Molecular Immunology (CIM)0 个研究点开始时间: 2018年12月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients who meet the diagnostic criteria.
- •2. Patients with age greater than or equal to 18 years.
- •3. Patients who have signed the informed consent for the investigation
- •4. Patients with functional capacity according to ECOG from 0 to 1.
- •5. Virgin patients of oncospecific treatment.
- •6. Patients with life expectancy of more than six months.
- •7. Patients with normal hepatic, renal and hematologic functions defined by:
- •Hemoglobin greater than and equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion)
- •Total Leukocyte count greater than and equal to 3.0 x 109 / L
- •Absolute Neutrophil count greater than and equal to 1.5 x 109 / L
- •Absolute Eosinophil count with any value.
- •Concentrations of EGF with any value.
- •Platelet count greater and equal 100 x 109 / L
- •Bilirubin up to the normal upper limit.
- •TGP and TGO: up to and less than 1.5 times the upper limit for the normal value of the institution, or <5 times the upper limit for the normal value of the institution, if the existence of liver metastasis is known.
- •Alkaline phosphatase greater than and equal to 2.5 times the upper normal limit.
- •Creatinine: Within normal limits for each institution or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.
排除标准
- •1. Patients who have previously received onco-specific treatment.
- •2. Patients with acute, chronic, or inflammatory decompensated infectious diseases.
- •3. Patients of childbearing age who do not accept to use adequate contraceptive methods (intrauterine devices, barrier or tubal ligation methods, hormonal methods).
- •4. Pregnant or lactating patients.
- •5. Patients with acute allergic states or history of severe allergic reactions.
- •6. Patients that are not tributaries of receiving onco-specific treatment.
- •7. Patients with Brain Metastases.
研究者
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