Phase I Clinical Trial Of Gene Therapy For Hepatocellular Carcinoma By Intratumoral Injection Of TK99UN (An Adenoviral Vector Containing The Thymidine Kinase Of Herpes Simplex Virus)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to determine whether activation of a prodrug after intratumoral gene transfer is safe in humans, and to determine dose levels for further clinical development.
详细描述
The study is a phase I clinical trial evaluating the intratumoral injection of defective adenovirus containing HSVtk (the thymidine kinase of herpes simplex virus), in patients with advanced hepatocellular carcinoma that were not amenable to curative therapy. The study was conducted in a single center in Spain. Five consecutive cohorts of two patients received increasing doses of the vector by intratumoral injection and equal doses of either intravenous ganciclovir or oral valganciclovir. The dose received by each consecutive cohort of patients was progressively higher according to a prefixed scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unequivocal diagnosis of hepatocellular carcinoma according to histological confirmation or EASL-AASLD criteria
- •Contraindication for surgical treatment of the disease
- •Detectable disease by imaging
- •Ability to give informed consent and to express the willingness to fulfill protocol requirements during the study
排除标准
- •Current pregnancy or breast-feeding
- •Acute infection
- •Positive anti-HIV antibodies
- •Hematologic alterations not attributable to hypersplenism, or in any case, intense neutropenia and thrombocytopenia, defined as neutrophil count lower than 0,5/pL or platelet count lower than 20/pL
- •Participation in other clinical trial during the previous month
结局指标
主要结局
Adverse Events
时间窗: Daily for the first 16 day, monthly thereafter for 6 months, 3-monthly since then
次要结局
- Tumor response by WHO criteria(at day 63 and months 4, 6, 9 y 12)
研究者
Bruno Sangro Gomez-Acebo
Main investigator
Clinica Universidad de Navarra, Universidad de Navarra