NCT00978107已完成1 期
A Phase I, Open-label, Dose-escalating Study of the Safety or Percutaneous Intra-tumoral Injection of TG4023 (MVA-FCU1) Combined With Systemic Administration of 5-fluorocytosine in Patients With Primary or Secondary Hepatic Tumors.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Transgene
- 入组人数
- 16
- 试验地点
- 12
- 主要终点
- Maximal tolerated dose
研究概览
简要总结
This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with advanced disease without any other standard of care treatment options:
- •hepatic metastases of colorectal cancer (CRC) or of other cancers
- •Hepatocellular carcinoma (HCC)
- •At least one unresectable target tumor located in the liver, measuring 2-5 cm and accessible to IT administration of TG4023 and amenable to radiological measurement using RECIST,
- •Weight ≤ 100 kg,
- •Patients with stable disease, who have to discontinue chemotherapy because of intolerance,
- •ECOG performance status ≤ 2,
- •Life expectancy ≥ 3 months,
- •Hematology:
- •Absolute neutrophil count > 1,500/mm3,
- •Hemoglobin > 9g/dL,
- •Platelet count > 100,000/mm3,
- •Prothrombin time international normalized ratio (INR) ≤ 2; partial thromboplastin time ≤ 1.66 times upper limit of normal (ULN),
- •Biochemistry:
- •Total bilirubin ≤ 3 x ULN,
- •Aspartate amino-transferase (AST), alanine amino-transferase (ALT), alkaline phosphatase
- •5.0 x ULN,
- •Creatinin clearance ≥ 40 mL/min,
- •Total albumin ≥ 30 g/L,
- •Anti-vitamin K anticoagulants should have been switched for low-molecular weight heparin prior to TG4023 injection,
- •Signed, written Independent Ethics Committee (IEC)-approved informed consent.
排除标准
- •Child-Pugh stage C hepatic insufficiency,
- •Impaired renal function (creatinin clearance < 40 mL/min),
- •Known deficiency in dihydropyrimidine dehydrogenase (DPD) or total DPD deficiency diagnosed at baseline in those patients not previously treated with 5-FU-related compounds,
- •Brain metastases,
- •Significant impairment of gastro-intestinal (GI) tract absorption capacity, such as total gastrectomy, gastric mucosal atrophy, extensive intestinal resections or malabsorption disease will not be treated by oral 5-FC,
- •History of bleeding disorders,
- •Pregnant or breast-feeding women,
- •Human Immunodeficiency Virus (HIV) positive,
- •Chronic use of immunodepressants within 4 weeks prior to TG4023 injection or immune-depressed patients,
- •Hypersensitivity to 5-FC,
- •Hypersensitivity to egg proteins,
- •Concomitant or previous chemotherapy or targeted therapy within 4 weeks prior to TG4023 injection and last treatment with bevacizumab (Avastin®) within 2 months prior to TG4023 injection,
- •Concomitant treatment with anti-inflammatory drugs: systemic cortico-steroids and non-steroidal anti-inflammatory drugs (NSAIDs),
- •Prior gene therapy,
- •Prior participation in any other research protocol involving an IMP within 2 months prior to TG4023 injection,
- •Major surgery within 6 weeks of TG4023 injection,
结局指标
主要结局
Maximal tolerated dose
时间窗: 6 months
次要结局
- Tumor response of injected and non-injected lesions Viral dissemination Proof of concept: 5-FU concentration in plasma and in tumors(1 year)
研究者
研究点 (12)
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