EUCTR2015-000530-30-DK进行中（未招募）1 期
T cell therapy for patients with advanced Ovarian Cancer
Center for Cancer Immune Therapy0 个研究点开始时间: 2015年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（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 clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Histological proven advanced ovarian cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must be high grade serous carcinoma.
- •2. Progressive or recurrent resistant disease after platin-based chemotherapy or progressive or recurrent disease after second line or additional chemotherapy
- •3. Age: 18 – 70 years
- •4. ECOG performance status of =1
- •5. Life expectancy of > 6 months
- •6. At least one measurable parameter in accordance with RECIST 1.1 –criteria’s
- •7. No significant toxicities or side effects (CTC = 1) from possible previous treatments, except sensoric- and motoric neuropathy (CTC = 2) and/or alopecia (CTC = 2).
- •8. Sufficient organ function.
- •9. Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment.
- •10. Signed statement of consent after receiving oral and written study information
- •11. Willingness to participate in the planned controls and capable of handling toxicities.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Patients with other cancers within 5 years.
- •2. Known hypersensitivity to one of the active drugs or one or more of the excipients.
- •3. Serious comorbidity or autoimmune disease.
- •4. Creatinine clearence < 70 ml/min (in selected cases it can be decided to include patients with a lower GFR with the use of a reduced dose of chemotherapy).
- •5. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
- •6. Severe allergies or previous anaphylactic reactions.
- •7. Pregnant women and women breastfeeding.
- •8. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, metothrexate among others).
- •9. Simultaneous treatment with other experimental drugs.
- •10. Simultaneous treatment with other systemic anti-cancer treatments.
- •11. Patients with active and uncontrollable hypercalcaemia.
研究者
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