ACTRN12609000675224已完成1 期
Adoptive Immunotherapy for Epstein-Barr virus associated Nasopharyngeal Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 15 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Age 15 years or above.
- •2. Geographically accessible for follow up
- •3. Informed consent (from patient, or patient and parent/guardian if aged < 16 years) Approved hospital interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without the use of an interpreter.
- •4. Eastern Cooperative Oncology Group performance status 0, 1, 2 or 3
- •5. Previously diagnosed with stage II, III or IV nasopharyngeal carcinoma (NPC)
- •6. Life expectancy of at least 3 months.
排除标准
- •1. EBV negative tumour
- •2. Inability to identify an LMP/EBNA1 peptide to stimulate CTL cultures
- •3. Positive serology for human immunodeficiency virus (HIV)
- •4. Serology indicating active Hepititis B Virus (HBV) infection or carrier status for HBV (N.B. Positive serology for HBV indicating previous but cleared infection with HBV would not be an exclusion criteria.)
- •5. Serology indicating active Hepititis C Virus (HCV) infection
- •6. Significant non –malignant disease (e.g. severe cardiac or respiratory dysfunction)
- •7. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial
- •8. Prior cancers, except those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of < 5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix.
- •9. Currently receiving immunosuppressive therapy, including corticosteroids.
- •10. Pregnancy, or unwilling to use adequate contraception.
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