EUCTR2008-006168-12-DK进行中（未招募）1 期
Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer - CetIri
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with histological verified adenocarcinoma or Plano cellular carcinoma in oesophagus or ventricle, non-resectable or metastatic disease.
- •2. Patients with measurable or non-measurable disease.
- •3. Progressive disease during the first-line treatment or within 6 months after such.
- •4. Age = 18 years.
- •5. Performance status (WHO) 0-1.
- •6. Patients with an expected survival of at least 3 months.
- •7. Adequate hematologic function with neutrofilantal (ANC)1.5 x 109/l and platelets = 100 x 109 / l.
- •8. Normal liver function of bilirubin = 1.5 x ULN (upper limit of normal), at liver metastases no upper limit for ALT
- •9. Obtained signed informed consent in accordance with the requirements of the Science Ethics Committee.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment with Irinotecan, Cetuximab or another inhibitor of EGFR.
- •2. Prior or concomitant cancer with the exception of treated basal cell carcinoma in situ or cervical cancer.
- •3. Patients who are unable to follow treatment or evaluation plan.
- •4. Any state or therapy which investigators believe exposes the patient to a risk or affect experimental purposes.
- •5. No pregnant or nursing women. In fertile women it is ensured through a negative pregnancy test or use of safe contraceptives (the pill) the last 3 months before enrollment. Patients of childbearing age should use safe contraceptives (the pill) during the entire experimental treatment and at least 3 months after completion of therapy.
- •6. Patients with active infections or other serious concurrent medical conditions that might prevent the patient's ability to receive the protocol contested treatment
- •7. Known hypersensitivity to any of the components of reading
研究者
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