EUCTR2008-003925-17-IT进行中（未招募）不适用
Immunotherapy by autologous peripheral blood mononuclear cells and GM-CSF for hepatocellular carcinoma undergoing radiofrequency thermal ablation - HCC thermal ablation and immunotherapy combined treatment
AZIENDA OSPEDALIERA DI PARMA0 个研究点开始时间: 2009年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Multifocal HCC diagnosed by two concordant radiological examinations (US- CT scan) or by a single radiological examination and alpha-fetoprotein serum levels above 400 ng/ml, or histological diagnosis. Multifocal HCC with more than 3 liver nodules, 3 cm in diameter or total diameter of 2 nodules above 9 cm. Tumoral mass not exceeding 30% of the whole liver volume. Liver functionality evaluated according Child-Pugh score, within A5 and B8. Clinical conditions compatible with RF execution: Child-Pugh score as above defined, platelets >50.000/microL, prothrombin activity >50%, no severe portal hypertension (oesophageal varices > F2 or severe congestive gatropathy). Stage B according to Barcelona Clinic Liver Cancer Group (BCLC) staging system. That means HCC not suitable for curative treatments by liver resection or percutaneus ablative treatments and no symptoms and without a clear indication of chemoembolization (TAE or TACE) because of the multifocality of the tumor disease. Chronic HCV infection, HBsAg negative, ALT and AST <4 normal values. Peripheral lymphomonocytes above1500/microL. Normal renal function (creatinine <1.5 mg/dl). Heart function within normal values with ejection fraction >50% evaluated by bidimensional US. Normal lung function (PaO2>90 mmHg, PaCO2<42 mmHg). Age between 18 and 75. Patient capacity to understand informed consent. Geographical and logistic patient access to the medical center for a regular follow-up. Signed consent form.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Lack to fulfill the above described inclusion criteria Contraindication for RF treatment Less than 6 moths life expectancy Uncontrolled ongoing systemic infections Severe pharmacological intolerance (i.e. previous anaphylaxis) Pregnancy or breast feeding Severe immunosuppression or HIV infection Severe autoimmune disease undergoing immunosuppressive treatment Recent (last 3 months) or ongoing chemotherapy with the exception of the multikinase inhibitor sorafenib started by at least 3 month, without any significant toxic effect (CTC grade III and IV). Concomitant malignant neoplasia of different origin (with the exception of cutaneous basalioma) Any other clinical condition that could represent an impediment for enrolment as judged by the medical doctors involved in the study protocol.
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