KCT0000986招募中未知
A prospective, randomized multicenter, open-label, safety and preliminary efficacy study of Immunotherapy in patients with unresectable hepatocellular carcinoma (HCC) treated by transarterial chemoembolization (TACE)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Patient must be diagnosed with primary or recurrent hepatocellular carcinoma ineligible for local ablation therapies or surgical resection via one of the following methods
- •1) Diagnosed as HCC by histology or cytology
- •2) Diagnosed as HCC based on a typical profile with at least one contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI)
- •2. The following tumor characteristics by contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI)
- •1) There are 4 or more viable intra-hepatic lesions (1 lesion >1 cm diameter), or 2 to 3 viable intra-hepatic lesions (1 lesion >3 cm diameter)
- •2) The patients who are unable to secure sufficient resection lesion; intra-hepatic lesion >5 cm diameter
- •3) No evidence of invasion into the major portal or hepatic vein branches
- •3. Patient has not received local therapy or has received local therapy at least 3 months prior to participate this study
- •4. Patient who has an inadequate response to curative resection or local ablation
- •5. Child-Pugh score = 6 points
- •6. ECOG performance status of 0 or 1
- •7. Patient must has a life expectancy of at least 6 months.
- •8. Adequate haematological function
- •Hb >8.5 g/L, WBC = 2,000/mm^3, Absolute neutrophil count >1.5x10^9/L, platelet count = 50 x 10^9
- •9. Adequate hepatic function
- •Bilirubin = 50 µmol/L, AST or ALT = 5 x ULN /L
- •10. Adequate renal function: serum creatinine < 1.7 mg/dL
- •11. Patient is able to provide written informed consent(=19 years of age)
排除标准
- •1. Patient has diffuse type of HCC only.
- •2. Documented invasion of the main portal vein or extra-hepatic metastasis(including lymph node metastasis)
- •3. Patient has a history of liver transplantation
- •4. Patient has ascites or pleural effusion or pericardial fluid not controlled with diuretic therapy.
- •5. Clinical symptoms of hepatic encephalopathy
- •6. Patient with immunodeficiency or autoimmune disease that might be aggravated by immunotherapy
- •7. Patient is currently with Bacterial, viral, fungal, mycobacterial other infectious diseases(excluding chronic infection) or HIV infection
- •8. Serious concomitant disease (such as bowel paralysis, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes, renal failure, hepatic failure, heart failure, angina pectoris requiring medication or active gastrointestinal ulceration)
- •9. Medical history of thromboembolism requiring therapy except for the general treatment (pulmonary thromboembolism or cerebral infarction) within 12 months, or any paralysis due to thromboembolism before clinical enrollment
- •10. History of documented congestive heart failure, angina pectoris requiring medication, evidence of transmural myocardial infarction on electrocardiogram (ECG), clinically significant valvular heart disease, or an uncontrollable arrhythmia
- •11. Known anaphylactic hypersensitivity to iodinated contrast medium
- •12. Pregnant woman, nursing woman or woman is going to be pregnant within 6 months
- •13. Treatment with any investigational agent within 12 weeks of screening
- •14. Psychiatric disorder that may interfere with consent or protocol compliance.
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