NL-OMON46501招募中不适用
Adoptive T cell therapy in patients with recurrent ovarian cancer - OVACURE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >= 18 years.
- •OVACURE: Histologically proven epithelial ovarian cancer (EOC). Pre-OVACURE: Patients with stage IIIc or IV EOC that are treated with first line surgery can participate in the pre-OVACURE for TIL preservation out of the surgical specimen. In case of recurrent disease these TILs can be used.
- •Recurrent ovarian cancer
- •Presence of measurable progressive disease according to RECIST version 1.1 or
- •elevated CA125>2 times the upper normal limit (UNL) within 3 months and confirmed.
- •Expected survival of at least 3 months.
- •WHO performance status 0-2.
- •Within the last 2 weeks prior to study day 0, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
- •Hemoglobin >= 6,0 mmol/l
- •Granulocytes >= 1,500/µl
- •Lymphocytes >= 700/µl
- •Platelets >= 100,000/µl
- •Creatinine clearance >= 50 min/ml
- •Serum bilirubin <= 40 *mol/l
- •ASAT and ALAT <= 5 x the normal upper limit
- •LDH <= 2 x the normal upper limit
- •Viral tests:
- •o Negative for HIV type 1/2, HTLV and TPHA
- •o No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
- •o No antibodies against HCV (hepatitis C virus) in the serum
- •Able and willing to give valid written informed consent.
- •Prior treatment, including immunotherapy e.g. with anti-PD(L)1, is allowed but systemic therapy and radiotherapy must have been discontinued for at least two weeks before study entry.
- •Patients should have disease progression.
排除标准
- •Patients with brain metastases.
- •Clinically significant heart disease (NYHA Class III or IV).
- •Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
- •Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
- •Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and premalignant diseasein.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- •Lack of availability for follow-up assessments.
- •Pregnancy or breastfeeding
研究者
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