KCT0002996已完成未知
Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced hepatocellular carcinoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
pdate
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •1.Signed written informed consent.
- •2.Clinical or histological diagnosis of HCC based on the guidelines of the American Association for the Study of Liver Diseases.
- •3.At least one typical enhanced lesion that is bi-dimensionally measurable by multiphasic spiral CT scan or dynamic contrast-enhanced MRI.
- •4.Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) performed within 1 month prior to the enrollment:
- •- Hepatocellular carcinoma with major branch of portal vein invasion [from the third or lower order branch (Vp1) to main portal vein (Vp4),] on dynamic CT or MRI.
- •- If above item is satisfied and potential cause of death is expected to be intrahepatic HCC lesion, patients with extrahepatic metastasis (Lung, lymph node (any lymph node 1 cm), bone or brain) can be included in this study.
- •5.Age of at least 18 years and less than 80 years.
- •6.ECOG Performance Status of 0 or 1.
- •7.Child-Pugh class A or B (Child-Pugh score = 7).
- •8.Life expectancy of at least 16 weeks.
- •9.Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements (no transfusion, no restoration), conducted within 14 days prior to screening:
- •oHemoglobin = 8.0 g/dL
- •oAbsolute neutrophil count = 1,000/mm3
- •oPlatelet count = 50,000/µL
- •oTotal bilirubin <2.5 mg/dL
- •oSerum albumin =2.8 g/dL
- •oALT and AST < 5 × upper limit of normal
- •oPT-INR = 2.3 or Prothrombin Time-sec = 6 sec
- •oSerum creatinine = 1.7 mg/d
排除标准
- •1.A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy or cytotoxic chemotherapy for the treatment of HCC
- •2.Invasion of inferior vena cava (Vv3), or invasion of first order branch of the biliary duct (B3)
- •3.History or presence of hepatic encephalopathy
- •4.Ascites, moderate, large or intractable
- •5.Active clinically serious infections (> grade 2, NCI-CTC version 4.0), including spontaneous bacterial peritonitis.
- •6.Untreated active chronic hepatitis B
- •7.Esophageal or gastric varices= F2 (grade 2) with red color sign positive without prophylaxis (non-selective beta-blocker or endoscopic variceal ligation) or history of variceal bleeding without endoscopic variceal ligation/ injection sclerosis
- •8.Active ulcer of stomach or duodenum: untreated or presence of visible vessel
- •9.Any major surgery within 4 weeks, or any minor surgery within 2 weeks prior to signing the informed consent form
- •10.Candidate for liver transplant and a history of liver transplantation
- •11.History of cardiac disease: congestive heart failure greater than NYHA class 2; active coronary artery disease; cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus
- •12.History of AIDS/HIV infection.
- •13.Seizure disorder requiring medication.
- •14.History of organ allograft.
- •15.Evidence or history of bleeding diathesis, or thromboembolic events requiring treatment
- •16.Current renal dialysis.
- •17.Previous or concurrent cancer that has a primary site or histology distinct from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis, and T1] or any cancer curatively treated less than 3 years prior to enrollment.
- •18.History of alcohol abuse (male > 210g/week, female >140g/week)
- •19.Any contraindication for chemoembolization except major branch of portal vein invasion
- •- Extensive tumor with massive replacement of both entire lobes
- •- Technical contraindications to hepatic intra-arterial treatment, e.g. untreatable arteriovenous fistula
- •- Bile-duct occlusion or incompetent papilla due to stent or surgery
- •20.Any contraindication for doxorubicin administration
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