Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
研究概览
简要总结
The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.
详细描述
Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up thereafter. Additional endpoints will include blood biochemistry indices and safety monitoring.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
- •HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan, and AFP serum test higher or equal to 30 IU/ml.
- •All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
- •Health score status at baseline.
- •Agreement to participate in the study and to give at least 3 samples of blood for lab tests.
- •Readily available home or o other address where patient can be found.
排除标准
- •Subjects who might have already taken V5 in prior trials and have no baseline data.
- •Those who met inclusion criteria can be retrospectively enrolled.
- •Pregnant or breast-feeding women are excluded.
- •Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any locally available immune modulators, and any other therapeutic or preventive HCC vaccine.
- •Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry.
- •Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to HCC.
- •Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
研究组 & 干预措施
Daily oral dose of hepcortespenlisimut-L
Hepcortespenlisimut-L (V5) (850 mg pill) to be administered once per day for the duration of study
干预措施: Daily oral dose of hepcortespenlisimut-L (Biological)
结局指标
主要结局
Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
时间窗: minimum 3 months
monthly check-up of AFP serum levels
Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
时间窗: minimum 3 months
Comparison of abdominal CT scans at baseline and 3 months later
次要结局
- Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters(3 months)
- Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance(3 months)