NCT00562666终止1 期
Immunotherapy of Hepatocellular Carcinoma by Hepatic Intra Arterial Injection of Autologous Gamma-delta T Lymphocytes: A Phase I Study
Rennes University Hospital5 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
研究概览
简要总结
For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adult over 18
- •Hepatocellular carcinoma histologically proven, with at least one measurable tumor
- •Non operable tumor
- •Alfa foeto protein > 400 ng/ml
- •Other treatments (surgery, chemoembolization) non indicated
- •Chemoembolization non indicated due to good performance status (WHO 1) or to tumor volume
- •Performance status WHO < 2
- •Life expectancy > 3 months
- •Non inclusion Criteria:
- •Extra hepatic metastases
- •Severe hepatopathy (Child B or C)
- •Virus B or C chronic hepatitis
- •Chronic cardiac failure
- •Uncontrolled severe infectious disease
- •Other cancer, if not considered as cured
- •Positive serology for HIV or HTLV
- •Leucocytes < 3000/mm3 or neutrophils < 1500/mm3
- •Platelets < 80000/mm3
- •Serum creatinine > 110 µmol/L
- •Bilirubin > 35 µmol/L
- •AST, ALT, alkaline phosphatase > 5N
- •Current immunosuppressive treatment
- •Impossibility to comply with scheduled follow-up
- •Anatomical situation not permitting the selective injection of the product of cell therapy
- •Pregnant or breastfeeding woman, or not using adequate effective contraceptive method
- •Exclusion Criterion:
- •Insufficient number of gamma delta lymphocytes after expansion
排除标准
- 未提供
结局指标
主要结局
Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction
时间窗: Within 14 days after treatment
次要结局
- Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria.(3 months)
研究者
研究点 (5)
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