Phase III Randomized, Placebo-controlled Clinical Trial of Hepcortespenlisimut-L (Hepko-V5) Versus Placebo in Patients With Advanced Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- changes in plasma AFP
研究概览
简要总结
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma.
详细描述
Phase III, randomized, placebo-controlled, double-blinded trial aimed to seek the therapeutic benefit of hepcortespenlisimut-L (Hepko-V5) in subjects with advanced hepatocellular carcinoma. The results will be compared to placebo. The trial duration is 3 months and will consist of one stage with baseline laboratory evaluation including AFP levels with follow-up at monthly intervals. In addition pre-entry abdominal CT scan and end-study CT scan will be preformed. The clinical evaluation will be quantified according to special performance questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
placebo
placebo
干预措施: Placebo (Biological)
hepcortespenlisimut-L
Experimental placebo-controlled clinical of hepcortespenlisimut-L (V5) therapeutic vaccine against HCC
干预措施: hepcortespenlisimut-L (Biological)
结局指标
主要结局
changes in plasma AFP
时间窗: 3 months
Changes in plasma AFP levels at monthly intervals
次要结局
- CT scan(3 months)
研究者
Aldar Bourinbaiar
Investigator
Immunitor LLC