Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- presence and characterization of anti-HPV immune responses in patients in complete remission
研究概览
简要总结
Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.
In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.
In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.
The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status ≤ 1
- •patient with metastatic anal cancer HPV+
- •presence of a measurable target lesion according to radiological criteria (Recist V1.1)
- •patient with more than 12 months of complete remission of metastatic anal cancer according to radiological criteria (Recist V1.1)after treatment by DCF regimen (Docetaxel, Cisplatin and 5-Fluorouracil)
排除标准
- •pregnancy or lactation
- •patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
研究组 & 干预措施
patients in complete response
干预措施: DCF regimen (Drug)
结局指标
主要结局
presence and characterization of anti-HPV immune responses in patients in complete remission
时间窗: 3 months after sample
次要结局
- progression free survival(from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months)
- global survival(from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months)