EUCTR2011-000051-16-DE进行中（未招募）不适用
A Phase 2b Randomized Open-Label Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients with Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment. - TRAVERSE
Jennerex, Inc0 个研究点目标入组 120 人开始时间: 2011年11月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Advanced HCC: patients are not eligible for, or had disease progression after, local-regional therapy (e.g. surgery, TACE, RFA, ethanol injection)
- •Diagnosis of primary HCC by tissue biopsy, or clinical diagnosis based on EASL-EORTC guidelines
- •Previously treated with sorafenib and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression
- •Any side-effects from previous sorafenib therapy have resolved to Grade 1 or better, or are well-controlled with medication in the opinion of the Investigator
- •ECOG performance status 0, 1 or 2
- •Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
- •Serum creatinine =2.0 mg/dL or creatinine clearance =60 mL/min according to Cockroft-Gault formula.
- •Hematocrit =30% or Hemoglobin =10 g/dL (correction with transfusion or erythropoietin based therapy allowed to meet eligibility criteria)
- •No ongoing (other than HCC) or prior malignancy except for the following: dequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years.
- •For patients who are sexually active: patient must be able and willing to abstain for a minimum of 3 weeks after each treatment and subsequently use barrier contraception method for at least 6 weeks after each treatment of JX-594
- •Tumor status (as determined by radiology evaluation):
- •- Measurable viable tumor in the liver (=1 cm longest diameter [LD] and enhancing on arterial phase of triphasic CT scan or MRI), and injectable under imaging-guidance (CT and/or ultrasound)
- •- At least one intrahepatic tumor that has not received prior local-regional treatment, or that has exhibited >25% increase in viable tumor size since prior local-regional treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Major surgery within 28 days of randomization or subcutaneous venous access device placement within 7 days prior to randomization
- •Locoregional therapy within 28 days prior to randomization
- •Received sorafenib within 14 days prior to randomization
- •Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization (6 weeks in case of mitomycin C or nitrosoureas)
- •Prior treatment with JX-594
- •Prior or planned organ transplant
- •Platelet count < 50,000 PLT/ mm3
- •Total white blood cell (WBC) count < 2,000 cells/mm3
- •Prior or planned organ transplant (e.g. liver transplant)
- •Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
- •History of inflammatory skin condition
- •Severe or unstable cardiac disease
- •Viable CNS malignancy associated with clinical symptoms
- •Anticoagulant or anti-platelet medication that cannot be interrupted prior to IT injection
- •Pregnant or breastfeeding
研究者
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