A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Number of Participants With Radiographic Response
研究概览
简要总结
This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.
详细描述
This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.
Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).
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
- •Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC)
- •Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
- •ECOG performance status 0, 1 or 2
- •Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
- •Platelet count ≥50,000 plts/mm3
- •WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3
- •Hemoglobin ≥10 g/dL
- •Adequate liver function
排除标准
- •Received sorafenib as previous treatment for HCC for more than 14 days
- •History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for > 4 weeks)
- •Prior treatment with JX-594
- •Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
- •Severe or unstable cardiac disease
- •Viable CNS malignancy associated with clinical symptoms
- •Pregnant or nursing an infant
- •Significant bleeding event within the last 12 months.
结局指标
主要结局
Number of Participants With Radiographic Response
时间窗: CT scans every 6 week from Week 6 up to 12 months
Number of Participants with Complete response \[CR\] or partial response \[PR\] per modified Response Evaluation Criteria in Solid Tumors (mRECIST) for target and non-target lesions assessed by enhanced CT scan: CR, disappearance of intratumoral enhancing area; PR, \>=30% decrease in sum of diameters of enhancing area; Radiographic Response = CR + PR
次要结局
- Overall Survival (OS)(CT scans every 6 week from Week 6 up to 12 months)
- Time to Progression (TTP)(CT scans every 6 week from Week 6 up to 12 months.)