RPCEC00000199尚未招募2 期
Efficacy and safety of acotumomab-alum vaccine (Vaxira®) as maintenance treatment of recurrent platinum-sensitive epithelial ovarian cancer (EOC)
Center of Molecular Immunology0 个研究点目标入组 88 人开始时间: 2015年7月8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
- 入组人数
- 88
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: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- Female
入选标准
- •1. Patients with recurrent platinum-sensitive epithelial ovarian cancer
- •2. Patients with 18 years and older.
- •3. Patients who have signed informed consent .
- •4. Patients with performance status according to ECOG of 0-2.
- •5. Patients who have received only two platinum-based ChT schemes (the first-line treatment and treatment for relapsed platinum-sensitive), and achieve a complete or partial response within that treatment.
- •6. Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed two months.
- •7. Patients with hepatic, renal and haematological normal functions defined by:
- •Hemoglobin 90 g / L (patients with lower levels of Hb should be transfused prior to inclusion)
- •Leukocyte Count Total 3.0 x 109 / L
- •Absolute Neutrophil Count 1.5 x 109 / L
- •Platelet count 100 x 109 / L
- •Bilirubin to the upper limit of normal.
- •TGP and TGO: up 1.5 times the upper limit of normal value of the institution, or <5 times the upper limit of normal value of the institution, if known the existence of liver metastases.
- •Alkaline phosphatase 2.5 times the ULN.
- •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 treatment with the anti-idiotype alumina Racotumomab-vaccine or any other product on research.
- •2. Pregnant or lactating patients.
- •3. Patients with acute allergic conditions or history of severe allergic reactions.
- •4. patients with brain metastases.
- •5. Patients with stable disease or progression at the end of oncospecific treatment for platinum-sensitive relapse.
- •6. Patients with other cancer diagnosed in the last five years (excluding non-melanoma skin cancer, thyroid cancer and cervical cancer, successfully treated).
研究者
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